Reported Jun 19, 2024 · Ongoing
VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled…
Ortho-Clinical Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics, Inc. · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3
- X labelled Calibrator tube (1 per level
C1 - greenC2 - yellowC3 - red)
- Lot codes and dates
- Model No. 6801926; GTIN# 10758750001699; Lot 9010 (Manufactured 13-Oct-2023; Expiry 15-Jul-2024) and 9030 (Manufactured 09-Dec-2023; Expiry 26-Aug-2024).
- Amount recalled
- 481 units
Where it was sold
Why it was recalled
Potential for positively biased results due to signal reduction over shelf life.
This product could cause temporary or reversible health problems — stop using it.
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