Ortho Clinical Diagnostics Anti-B Bioclone diagnostic reagent recalled
Ortho Clinical Diagnostics Anti-B Bioclone reagent is recalled due to cold-chain failures during transit caused by severe thunderstorms. Products may have been stored outside recommended conditions, potentially increasing the risk of incorrect or delayed test 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: This is an FDA Class II recall involving a medical device with potential for incorrect or delayed test results. No reported illnesses or injuries are stated in the source, making this a precautionary recall based on a potential failure condition rather than confirmed harm.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling Ortho Clinical Diagnostics Inc Anti-B Bioclone 10ML (3×10ML) diagnostic reagent. The recall was initiated due to transit delays of this cold-chain product during severe thunderstorms, which may have caused the products to be stored outside the manufacturer's recommended labeled storage conditions.
This storage failure could increase the probability of an incorrect test result or a delayed test result. The affected product has Catalog No. 6901935, GTIN 10758750007448, and Order No. 46044105.
The product was distributed nationwide in the following states: Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. Customers who received affected units should contact their supplier or the recalling firm for guidance on product replacement or further instructions.
The recalled product
- Product
- ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-excursion
- incorrect-test-result
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 (3)
- Catalog No. 6901935
- GTIN: 10758750007448
- Order No. 46044105.
Distribution
Distributed nationwide across the United States.
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