Calibration Gas 2
Calibration gas 2, 10bar on-board gas bottle for USA and Canada
1manufacturer
3catalogue numbers in this listing
13510(k) clearances naming this product code
14recalls 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 | Radiometer Medical APS, Denmark |
|---|---|
| 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 | Complaint-file establishment, Manufacturer |
| Record published | 2016-09-01 |
| Record revised | 2023-09-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -40 to 50 °C; Special storage condition: May burst if heated. Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. Prot |
| Distribution end date | 2023-09-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 962-175 | In distribution | |
| 962-170 | Withdrawn | |
| 962-141 | Withdrawn |
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 |
| Ready Sensor™ Lactate Biosensor | Siemens Healthcare Diagnostics Inc | 3 |
| Calibration gas 1 | Radiometer Medical APS | 3 |
Showing 12 of 235. All products under Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160153 | 2016-11-04 |
| K142898 | 2015-06-17 |
| K131988 | 2013-09-17 |
| K130144 | 2013-07-31 |
| K123748 | 2013-05-07 |
| K122729 | 2012-11-16 |
| K122642 | 2012-10-26 |
| K120197 | 2012-03-19 |
| K111897 | 2011-07-19 |
| K110416 | 2011-03-24 |
| K100777 | 2010-12-10 |
| K043218 | 2005-05-10 |
| K041874 | 2004-10-08 |
Recalls
14 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 |
|---|---|---|---|---|---|
| 2025-03-21 | Class II | Component design/selection | ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The analyzer software includes a feature (w | 6275 analyzers | |
| 2024-05-31 | Class II | Nonconforming Material/Component | Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specifi | 27,127 analyzers | |
| 2022-05-18 | Class II | Software design | There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+. | 1489 analyzers | |
| 2021-04-14 | Class II | Device Design | Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. | Total=4,135 analyzers world-wide (only 1277 analyzers within | |
| 2020-05-26 | Class II | Software design | Potential risk of patient mix-up on analyzers due to software issues. | 3,899 units | 2023-02-08 |
| 2020-05-26 | Class II | Software design | Potential risk of patient mix-up on analyzers due to software issues. | 4,615 units | 2023-02-08 |
| 2020-05-11 | Class II | Under Investigation by firm | Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode types not using a check digit for patient ID or accessi | 1981 | 2023-02-24 |
| 2020-05-11 | Class II | Under Investigation by firm | Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode types not using a check digit for patient ID or accessi | 9373 units | 2023-02-24 |
| 2020-03-10 | Class II | Software design | Analyzer’s barcode reader misinterprets the contents of barcode label used for entering patient ID or accession number. The issue is related to barcode types not using a check digit. This could result in patient mixup or loss of sample res | 3,656 units | 2022-10-31 |
| 2020-03-06 | Class II | Component design/selection | Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could | 2 units | |
| 2020-02-03 | Class II | Software design | The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. T | 3,968 units | 2022-09-20 |
| 2019-11-21 | Class II | Nonconforming Material/Component | The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the received light has not been transmitted | 544 | 2024-11-08 |
| 2019-11-21 | Class II | Nonconforming Material/Component | The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the received light has not been transmitted | 1233 units | 2024-11-08 |
| 2018-02-27 | Class II | Device Design | There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may result in patient mix-up. | 2 | 2019-03-20 |
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.