Ortho-Clinical Diagnostics Recalls Vitros Anti-HBs Reagent Packs Due to Calibration Failure
Ortho-Clinical Diagnostics is recalling specific lots of Vitros Anti-HBs Reagent Packs because they may fail to obtain a valid calibration.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a technical calibration failure rather than a direct safety hazard like contamination or injury.
Plain-English summary
Ortho-Clinical Diagnostics is recalling certain lots of Vitros Anti-HBs Reagent Packs. These products are used for the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum.
The recall is being conducted because the affected reagent packs have an inability to obtain a valid calibration. The specific lots involved are 6630 (expiration 2/26/2013), 6740 (expiration 6/18/2013), and 6750 (expiration 6/11/2013).
A total of 1,464 units were distributed worldwide, including in the United States and various international locations. Users of these products should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum.
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
- Affected units
- 1,464
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 (2)
- Lot #'s 6630 expiration 2/26/2013
- Lot # 6740 expiration 6/18/2013 and Lot # 6750 expiration date 6/11/2013.
Distribution
Distributed nationwide across the United States.
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