VITROS Immunodiagnostic Products Anti-HBs Quantitative recall
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators…
Why was VITROS Immunodiagnostic Products Anti-HBs Quantitative recalled?
Affected lots may experience increased calibration failures or an increase in falsely elevated results.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI 10758750001682 Lots 8931 8940 8955 8960 8970 8980 8990
- Product
- VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators…
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Quantity
- 6,920 US; 57 OUS
- Distribution
- Domestic distribution nationwide. OUS distribution to Bermuda, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Russia, Denmark, Norway, Sweden, France, Belgium, and The Netherlands.
- Recall date
- January 31, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)