Abbott Diagnostics Alinity I Free PSA Reagent Recall Due to Cold Chain Failure
Cold chain storage failures during transit of Abbott Diagnostics Alinity I Free PSA reagent, caused by severe thunderstorms, may result in incorrect or delayed test results. Units were distributed across 11 U.S. states.
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: FDA Class II recall with theoretical risk of incorrect or delayed diagnostic test results due to cold chain storage failure. No illnesses or injuries have been reported; the hazard is precautionary. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
This is a Class II FDA recall of Abbott Diagnostics Alinity I Free PSA (prostate-specific antigen) reagent test kits. The products were affected by transit delays involving severe thunderstorms that caused them to be stored outside recommended temperature conditions.
The storage temperature failure could increase the probability of incorrect test results or delayed test results. No illnesses or injuries have been reported to date.
Affected units were distributed nationwide in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. Healthcare providers and laboratories with affected inventory should contact the manufacturer for guidance on product replacement or revalidation.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- storage-temperature-failure
- test-result-inaccuracy
- delayed-results
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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