FDAClass IIJune 4, 2025

Abbott Diagnostics Alinity I Anti-ccps Reagent recall

ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT.

Why was Abbott Diagnostics Alinity I Anti-ccps Reagent recalled?

transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog No. 09P2720; GTIN: 380740151362; Order No. 46050138.

Product
ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT.
Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
Quantity
1 unit
Distribution
US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
Recall date
June 4, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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