GEM Premier 5000 PAK BG/ISE/Coox 150 Test
GEM 5000 BG ISE COOX 150 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge)
1manufacturer
2catalogue numbers in this listing
16510(k) clearances naming this product code
35recalls on this code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Record
| Listed by | Instrumentation Laboratory SPA, Italy |
|---|---|
| FDA product code | CHL |
| Device type | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1120 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K160225 |
| Record published | 2018-01-24 |
| Record revised | 2023-08-04 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 15 to 25 °C; Special storage condition: STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00055415008 | In distribution | |
| 00055415008XC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 80 |
| ABL80 SC80 | Radiometer Medical APS | 66 |
| ABL77 Sci | Radiometer Medical APS | 14 |
| Electrode for ABL analyzers | Radiometer Medical APS | 7 |
| Calibration Solution | Radiometer Medical APS | 7 |
| i-STAT | Abbott Point OF Care Inc. | 6 |
| ABL90 Sensor Cassette pack | Radiometer Medical APS | 6 |
| GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 450 Tests) | Instrumentation Laboratory SPA | 5 |
| Nova | Nova Biomedical Corporation | 4 |
| GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX/Tbili 150 Tests) | Instrumentation Laboratory SPA | 4 |
| Calibration Gas 2 | Radiometer Medical APS | 3 |
| Ready Sensor™ Lactate Biosensor | Siemens Healthcare Diagnostics Inc | 3 |
Showing 12 of 235. All products under Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223608 | 2023-08-10 |
| K203790 | 2021-08-20 |
| K173403 | 2017-12-29 |
| K160412 | 2016-12-14 |
| K133407 | 2014-01-13 |
| K061974 | 2006-09-15 |
| K992834 | 1999-11-24 |
| K963800 | 1996-11-13 |
| K955793 | 1996-02-14 |
| K935069 | 1994-03-28 |
| K913927 | 1991-10-11 |
| K890827 | 1989-06-20 |
| K821483 | 1982-06-10 |
| K820744 | 1982-04-15 |
| K800757 | 1980-04-21 |
| K760969 | 1977-01-12 |
Recalls Naming This Product
26 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Instrumentation Laboratory SPA | 510(k) number | 2026-05-21 | Class II | Nonconforming Material/Component | The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and to | 109 units |
| Instrumentation Laboratory SPA | 510(k) number | 2026-05-08 | Class II | Software Design Change | BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the “price c | 0 US, 118 OUS |
| Instrumentation Laboratory SPA | 510(k) number | 2026-05-08 | Class II | Software Design Change | BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the “price c | 27 |
| Instrumentation Laboratory SPA | 510(k) number | 2026-05-08 | Class II | Software Design Change | BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the “price c | 67 |
| Instrumentation Laboratory SPA | 510(k) number | 2026-05-08 | Class II | Software Design Change | BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the “price c | 21 |
| Instrumentation Laboratory SPA | 510(k) number | 2026-05-08 | Class II | Software Design Change | BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the “price c | 3 |
| Instrumentation Laboratory SPA | 510(k) number | 2026-01-20 | Class II | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, | 51 units |
| Instrumentation Laboratory SPA | 510(k) number | 2026-01-20 | Class II | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, | 30 units |
| Instrumentation Laboratory SPA | 510(k) number | 2026-01-20 | Class II | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, | 1,225 units |
| Instrumentation Laboratory SPA | 510(k) number | 2026-01-20 | Class II | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, | 10 units |
| Instrumentation Laboratory SPA | 510(k) number | 2026-01-20 | Class II | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, | 489 units |
| Instrumentation Laboratory SPA | 510(k) number | 2026-01-20 | Class II | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, | 180 units |
| Instrumentation Laboratory SPA | 510(k) number | 2026-01-20 | Class II | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, | 1,126 units |
| Instrumentation Laboratory SPA | 510(k) number | 2026-01-20 | Class II | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, | 27 units |
| Instrumentation Laboratory SPA | 510(k) number | 2026-01-20 | Class II | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, | 352 units |
| Instrumentation Laboratory SPA | 510(k) number | 2026-01-20 | Class II | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, | 8 units |
| Instrumentation Laboratory SPA | 510(k) number | 2026-01-20 | Class II | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, | 195 units |
| Instrumentation Laboratory SPA | 510(k) number | 2026-01-20 | Class II | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, | 1,629 units |
| Instrumentation Laboratory SPA | 510(k) number | 2026-01-20 | Class II | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, | 7 units |
| Instrumentation Laboratory SPA | 510(k) number | 2026-01-20 | Class II | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, | 253 units |
| Instrumentation Laboratory SPA | 510(k) number | 2026-01-20 | Class II | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, | 74 units |
| Instrumentation Laboratory SPA | 510(k) number | 2026-01-20 | Class II | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, | 1,607 units |
| Instrumentation Laboratory SPA | 510(k) number | 2026-01-20 | Class II | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, | 25 units |
| Instrumentation Laboratory SPA | 510(k) number | 2026-01-20 | Class II | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, | 130 units |
| Instrumentation Laboratory SPA | 510(k) number | 2026-01-20 | Class II | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, | 70 units |
| Instrumentation Laboratory SPA | 510(k) number | 2026-01-20 | Class II | Nonconforming Material/Component | Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, | 1,989 units |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-05-21 | Class II | Nonconforming Material/Component | The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-O | 32 units | |
| 2026-05-08 | Class II | Software Design Change | BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the “price c | 4 US | |
| 2023-09-29 | Class II | Under Investigation by firm | Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications f | 2448 total | |
| 2023-09-29 | Class II | Under Investigation by firm | Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications f | 2448 units | |
| 2023-09-29 | Class II | Under Investigation by firm | Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications f | 2448 units | |
| 2011-05-11 | Not classified | Software design | Software upgrade: misuse of the barcode gun by repeatedly clicking can cause the instrument to attach test results to an incorrect patient ID. | 840 units | 2013-03-15 |
| 2007-03-27 | Not classified | Other | Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result | 210 | 2012-05-23 |
| 2003-03-07 | Not classified | Other | Incorrect bar code applied to cartridges could result in inaccurate pO2 value | 16 | 2012-05-23 |
| 2003-03-07 | Not classified | Other | Incorrect bar code applied to cartridges could result in inaccurate pO2 value | 2 | 2012-05-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.