Ready Sensor™ Lactate Biosensor
Ready Sensor™ Lactate Biosensor, an in vitro diagnostic medical device for the measurement of lactate in Siemens Healthcare Diagnostics RAPIDLab® Series systems - Single Lactate Warranty…
Ready Sensor™ Lactate Biosensor, an in vitro diagnostic medical device for the measurement of lactate in Siemens Healthcare Diagnostics RAPIDLab® Series systems – Single Lactate Warranty Replacement
1manufacturer
3catalogue numbers in this listing
2510(k) clearances naming this product code
40recalls 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 | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| 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) | K934907 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-19 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Special storage condition: Do not freeze; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10311032 | 4 | In distribution | |
| 10334138 | In distribution | ||
| 10316526 | 2 | 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 |
| 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 |
|---|---|
| K192240 | 2020-03-27 |
| K122539 | 2013-04-19 |
Recalls
37 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 |
|---|---|---|---|---|---|
| 2026-04-02 | Class II | Under Investigation by firm | Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can | 71725 (38025 US, 33700 OUS) | |
| 2025-06-26 | Class II | Under Investigation by firm | Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride, pCO2, Glucose and Lactate | 1,477 units | |
| 2025-03-19 | Class II | Process control | The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n. | 5,207 units | |
| 2025-03-19 | Class II | Process control | The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n. | 264,252 units | |
| 2024-11-22 | Class II | Software design | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by | 6,738 units | |
| 2024-11-22 | Class II | Software design | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by | 320 units | |
| 2024-11-22 | Class II | Software design | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by | 670 units | |
| 2024-11-22 | Class II | Software design | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by | 2240 units | |
| 2024-11-22 | Class II | Software design | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by | 276 units | |
| 2024-11-22 | Class II | Software design | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by | 23 units | |
| 2024-11-22 | Class II | Software design | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by | 1 unit | |
| 2024-11-22 | Class II | Software design | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by | 3,011 units | |
| 2024-09-24 | Class II | Under Investigation by firm | Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 mmol/ | 1292 units | |
| 2024-05-17 | Class II | Software Design Change | Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary mode. With this software version, samples run in th | 9 units US | |
| 2023-10-19 | Class II | Software design | Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the results are run on the epoc NXS Host and Delete Blood Tes | 10,183 devices | |
| 2023-06-01 | Class II | Under Investigation by firm | There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range. | 3201 ea | |
| 2023-06-01 | Class II | Under Investigation by firm | There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range. | 348 ea | |
| 2023-06-01 | Class II | Under Investigation by firm | There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range. | 473 ea | |
| 2022-12-12 | Class II | Under Investigation by firm | pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure | 4,369 units | |
| 2022-12-12 | Class II | Under Investigation by firm | pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure | 22,156 units | |
| 2022-06-01 | Class II | Under Investigation by firm | Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support. | 263 Boxes | |
| 2020-05-27 | Class II | Software design | The scanner is not confirming the integrity of read barcode data using the check-digit when reading Code 39 barcodes. | 436 | 2021-01-12 |
| 2017-04-10 | Class II | Software design | Potential Patient Demographic Error with Blank Patient ID Field | 159 units | 2019-08-20 |
| 2016-08-11 | Class II | Software design | There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system | 2910 units | 2020-07-16 |
| 2016-08-11 | Class II | Software design | There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system | 144 units | 2020-07-16 |
| 2016-08-11 | Class II | Software design | There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system | 2602 units | 2020-07-16 |
| 2016-08-11 | Class II | Software design | There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system | 6786 units | 2020-07-16 |
| 2016-08-11 | Class II | Software design | There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system | 492 units | 2020-07-16 |
| 2016-08-11 | Class II | Software design | There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system | 197 units | 2020-07-16 |
| 2016-08-11 | Class II | Software design | There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system | 114 units | 2020-07-16 |
| 2012-09-17 | Class II | Software Manufacturing/Software Deployment | RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample | 274 units | 2015-04-01 |
| 2012-09-17 | Class II | Software Manufacturing/Software Deployment | RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample | 179 units | 2015-04-01 |
| 2012-09-17 | Class II | Software Manufacturing/Software Deployment | RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample | 828 units | 2015-04-01 |
| 2012-09-17 | Class II | Software Manufacturing/Software Deployment | RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample | 140 units | 2015-04-01 |
| 2012-09-17 | Class II | Software Manufacturing/Software Deployment | RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample | 2939 units | 2015-04-01 |
| 2012-09-17 | Class II | Software Manufacturing/Software Deployment | RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample | 2152 units | 2015-04-01 |
| 2012-09-17 | Class II | Software Manufacturing/Software Deployment | RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample | 4494 units | 2015-04-01 |
| 2009-10-30 | Not classified | Component design/selection | Software: Reference sensor failure may result in inaccurate pH reuslts | 4095 units | 2015-09-04 |
| 2009-10-30 | Not classified | Component design/selection | Software: Reference sensor failure may result in inaccurate pH reuslts | 998 units | 2015-09-04 |
| 2006-04-04 | Not classified | Software design | Invalid CO-oximeter values; Bayer HealthCare determined that under very specific conditions, the RapidLab 1245 or RapidLab 1265 systems may report invalid CO-oximeter values to an LIS, Rapidlink, or Rapidcomm data management system. | Domestic – 124 units, Foreign-364 units (all systems) | 2012-07-30 |
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.