ORTHO CLINICAL DIAGNOSTICS VITROS BUN Reagent Recall Nationwide
ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN clinical reagent is being recalled due to transit delays caused by severe thunderstorms that may have exposed products to improper storage conditions, risking 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 potential laboratory test inaccuracy due to storage-condition deviation. No reported illnesses or injuries are stated in the source text, and the hazard is precautionary rather than confirmed. The issue arises from a one-time environmental event (thunderstorms) affecting cold chain storage, making this a moderate voluntary precautionary recall.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) reagent (Catalog No. 8102204; GTIN: 10758750004362; Order No. 46047530). The recall was initiated because certain cold chain products experienced transit delays due to severe thunderstorms, which may have caused the products to be stored outside the recommended labeled storage conditions.
This failure in proper storage could increase the probability of an incorrect test result or a delayed test result. The product was distributed nationwide in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.
Healthcare facilities and laboratories that received affected products should review their records for the product codes listed above. Consult ORTHO CLINICAL DIAGNOSTICS or your supplier for instructions on product handling or replacement.
The recalled product
- Product
- ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- cold-chain-deviation
- test-inaccuracy
- storage-condition-failure
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. 8102204
- GTIN: 10758750004362
- Order No. 46047530.
Distribution
Distributed nationwide across the United States.
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