Ortho-Clinical Diagnostics recalls VITROS Performance Verifier I
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…
Read the official notice →- Date
- 2024-04-03
- Country
- United States
- Brand
- Ortho-Clinical Diagnostics
- Product
- VITROS Performance Verifier I
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Australia,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Ortho-Clinical Diagnostics recalls
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FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - 2024-06-12
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Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration…
The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is detectable by the user when the product fails to meet the…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide - US Nationwide and the country of Columbia.Official notice → - 2024-03-13
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Ortho-Clinical Diagnostics, Inc. recalls VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide - US Nationwide distribution in the states of AZ, CA, CT, FL, IA,…Official notice → - US
Ortho-Clinical Diagnostics, Inc. recalls VITROS 5600 Integrated System (New and Refurbished)
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2024-01-31
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Affected lots may experience increased calibration failures or an increase in falsely elevated results.
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Other drugs & medical recalls in the United States
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Olympus Corporation of the Americas recalls Insufflation unit, UHI-4.
Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stopping air supply due to the front panel LED turning off".
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Boston Scientific Corporation recalls Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
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