Abbott Diagnostics Alinity I Free PSA Reagent Affected by Storage Conditions
Abbott Diagnostics Alinity I Free PSA reagent units may have been stored outside recommended conditions due to transit delays from severe thunderstorms, potentially affecting test accuracy or timing.
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 diagnostic reagent with a potential for incorrect or delayed test results. However, no reported illnesses, injuries, or confirmed failures are stated in the source text; the hazard is based on storage condition deviation during transit. This meets the threshold for Moderate severity under the precautionary-recall category with identifiable but unconfirmed risk.
Plain-English summary
Abbott Diagnostics Alinity I Free PSA US (200 Test/EA) Reagent is being recalled due to transit delays caused by severe thunderstorms that may have resulted in storage outside the product's recommended labeled storage conditions.
The failure to maintain proper storage conditions could increase the probability of an incorrect test result or a delayed test result. Affected units were distributed nationwide to Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.
Users of this reagent should review their supply and contact Mckesson Medical-Surgical Inc. or Abbott Diagnostics if they have units potentially affected by this recall. Laboratory personnel should consider the implications for any test results generated using affected reagent lots.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- improper-storage
- test-accuracy-risk
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. 07P9321
- GTIN: 380740158330
- Order No. 46052126.
Distribution
Distributed nationwide across the United States.
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