VITROS 8231474Recalls & reported problems
Ortho-Clinical Diagnostics, Inc. · VITROS Chemistry Products Performance Verifier II · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 3
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
3 FDA recall records name this device's identifier, 3 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Jun 10, 2025Open, Classified
Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).
Z-2121-2025 · Root cause: Under Investigation by firm · FDA record ↗
- Feb 27, 2024Open, Classified
The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.
Z-1373-2024 · Root cause: Under Investigation by firm · FDA record ↗
- Oct 16, 2020Open, Classified
Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures
Z-0471-2021 · Root cause: Under Investigation by firm · FDA record ↗
Other Calibrator, secondary devices
- ARCHITECT 2K41-27Abbott Laboratories · CALIBRATOR, SECONDARY1 recall374 reports
- ARCHITECT 8K28-02Abbott Laboratories · CALIBRATOR, SECONDARY1 recall115 reports
- BioPlex 2200 12000651Bio-Rad Laboratories, Inc. · Calibrator, secondary3 recalls0 reports
- ARCHITECT 08K2803Abbott GmbH · Calibrator, secondary1 recall93 reports
- ARCHITECT 7K63-25Abbott Ireland · CALIBRATOR, SECONDARY108 reports
- VITROS 8067324Ortho-Clinical Diagnostics, Inc. · Calibrator, secondary2 recalls0 reports
- VITROS 8568040Ortho-Clinical Diagnostics, Inc. · CALIBRATOR, SECONDARY1 recall18 reports
- ARCHITECT 8K28-11Abbott Laboratories · CALIBRATOR, SECONDARY1 recall2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page