Ortho-Clinical Diagnostics Recalls VITROS Anti-HBs Calibrators and Reagent Packs
Ortho-Clinical Diagnostics is recalling VITROS Anti-HBs Calibrators and Reagent Packs because they may produce false positive results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations or significant injuries, fitting the criteria for a moderate severity score involving potential diagnostic errors without confirmed harm.
Plain-English summary
Ortho-Clinical Diagnostics has issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs. The recall involves 1,920 kits that were distributed nationwide to all states.
The products are being recalled due to the potential for false positive results. The affected items include specific product codes and lot numbers with expiry dates ranging from May 2013 to September 2013.
Healthcare facilities and laboratories should stop using these specific lots and contact Ortho-Clinical Diagnostics for further instructions on how to return or dispose of the affected products.
The recalled product
- Product
- VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
- Affected units
- 1,920
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Product Code 1) 6801926
- 2) 6801925
- 3) 6802452 Lot numbers: 1) 6700
- 2) 6731
- 3) 6830 Expiry Dates: 1) 21 May 2013
- 2) 24 July 2013
- 3) 11 Sept 2013
Distribution
Distributed nationwide across the United States.
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