VITROS phosphorus reagent recalled due to improper transit storage
Mckesson Medical-Surgical Inc. is recalling VITROS phosphorus reagent due to improper storage during transit caused by severe thunderstorms. The storage deviation could affect test result accuracy.
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: FDA Class II recall with no reported illnesses or adverse events. The storage condition deviation poses a theoretical risk to test accuracy, representing a precautionary recall with no documented product failures or patient harm.
Plain-English summary
ORTHO CLINICAL DIAGNOSTICS INC VITROS phosphorus reagent is being recalled by Mckesson Medical-Surgical Inc. due to improper storage conditions during transit. The recall involves 10 units distributed to facilities in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.
Transit delays caused by severe thunderstorms resulted in products being stored outside the manufacturer's recommended labeled storage conditions. This storage deviation could increase the probability of incorrect test results or delayed test results.
Affected facilities should verify their inventory against the product details (Catalog No. 1513209; GTIN: 10758750009220) and contact Mckesson Medical-Surgical Inc. for guidance regarding affected product.
The recalled product
- Product
- ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (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. 1513209
- GTIN: 10758750009220
- Order No. 46094482.
Distribution
Distributed nationwide across the United States.
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