Clinical Diagnostic Reagent Recalled Due to Improper Storage During Transit
Ortho Clinical Diagnostics VITROS BUN reagent distributed nationwide may have been stored outside recommended conditions during transit due to severe thunderstorms, potentially causing incorrect or delayed test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II medical device recall involves a risk-of-harm product where injury has not yet been reported. Failure to maintain proper storage conditions for a clinical diagnostic reagent creates a genuine risk of incorrect or delayed test results, which could compromise diagnostic accuracy in patient care, justifying a High severity assessment per the rubric.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling Ortho Clinical Diagnostics VITROS BUN (60/CR 5CR/PK) clinical reagent. Severe thunderstorms during transit caused certain product shipments to be stored outside the labeled storage conditions. This storage failure could increase the probability of an incorrect test result or a delayed test result.
The recalled reagent was distributed nationwide to facilities in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. The affected product has Catalog Number 8102204, GTIN 10758750004362, and Order Number 46047530.
In clinical diagnostic settings, an incorrect or delayed test result could compromise the accuracy of patient testing and may affect appropriate clinical decision-making.
The recalled product
- Product
- ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- improper-storage
- incorrect-test-result
- delayed-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. 8102204
- GTIN: 10758750004362
- Order No. 46047530.
Distribution
Distributed nationwide across the United States.
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