Abbott Diagnostics Alinity I Anti-CCPS Reagent Recall
Abbott Diagnostics Alinity I Anti-CCPS Reagent is being recalled due to transit delays from severe thunderstorms that may have exposed the product to storage conditions outside the manufacturer's recommendations, potentially causing incorrect or delayed test results.
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 where storage deviation could affect test accuracy. The source text indicates no reported illnesses or incorrect results—only a potential risk from storage deviation. No hospitalizations or confirmed harms are documented, placing this at the Moderate level per the rubric.
Plain-English summary
Abbott Diagnostics Alinity I Anti-CCPS Reagent (Catalog No. 09P2720; GTIN: 380740151362; Order No. 46050138) is being recalled nationwide. The reagent was distributed to facilities in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.
The recall was initiated because severe thunderstorms caused transit delays of the cold chain product, resulting in storage outside the manufacturer's recommended labeled storage conditions. This failure to maintain proper storage could increase the probability of an incorrect test result or a delayed test result.
Customers who have received affected units should contact Mckesson Medical-Surgical Inc. Corporate Office for instructions on how to proceed. Healthcare providers should verify the storage history of their units and follow the manufacturer's guidance regarding suitability for continued use.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 1
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
Part of a larger recall action
This product is one of 32 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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