Recall Z-0772-2024— Ortho-Clinical Diagnostics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Ortho-Clinical Diagnostics, Inc., initiated 2023-11-27. FDA's recall record names no specific 510(k) clearance for this event. Product: VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926. Reason: Affected lots may experience increased calibration failures or an increase in falsely elevated results..
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-27
- Firm location
- Rochester, NY, United States
Product description
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
Reason for recall
Affected lots may experience increased calibration failures or an increase in falsely elevated results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.