Bio-Rad Anti-HBs Cutoff Calibrator Recalled for Incorrect Expiration Date
Bio-Rad Laboratories is recalling 20 vials of Anti-HBs Cutoff Calibrator because the expiration date printed on the label is incorrect.
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 indicates the product is not likely to cause adverse health consequences. The issue is a labeling error regarding the expiration date.
Plain-English summary
Bio-Rad Laboratories, Inc. is recalling 20 vials of the spare component Anti-HBs Cutoff Calibrator, Catalog number 26154. The product is sold separately from the MONOLISA Anti-HBs EIA Kit. The recall is due to an error in the expiration date printed on the label, which is listed as 2016-04-30.
The affected lot number is 11130382. The product was distributed in the United States to the states of Arizona, California, Idaho, Missouri, and New Hampshire.
Consumers and healthcare facilities should stop using the product and contact Bio-Rad Laboratories for further instructions.
The recalled product
- Product
- The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error.
- Manufacturer
- Bio-Rad Laboratories, Inc.
- Hazard
- Affected units
- 20
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 no. 11130382
- expiration date 2016-04-30
Distribution
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