Abbott Alinity I Anti-CCPS Reagent Recalled for Temperature Excursion
Abbott Diagnostics is recalling Alinity I Anti-CCPS Reagent after shipments may have been stored outside recommended temperature conditions during transit. This could result in 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: FDA Class II with no reported illnesses or injuries. This is a risk-of-harm product (diagnostic accuracy) where the hazard is theoretical and conditional—products may have been stored improperly, which could affect test accuracy. Per the rubric, risk-of-harm products with no reported injuries score as High (3).
Plain-English summary
Abbott Diagnostics is recalling Alinity I Anti-CCPS Reagent due to potential storage condition issues during transit. The reagent is used in laboratory diagnostic testing.
During recent severe thunderstorms, certain shipments experienced transit delays that may have resulted in the products being stored outside their recommended labeled storage conditions. Improper storage of diagnostic reagents can affect their performance.
This could increase the probability of incorrect test results or delayed test results. The recall affects products distributed nationwide in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.
Facilities that use this product should check whether they received affected shipments and contact their supplier or Abbott Diagnostics for product verification or replacement instructions.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-excursion
- test-inaccuracy
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. 09P2720
- GTIN: 380740151362
- Order No. 46050138.
Distribution
Distributed nationwide across the United States.
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