Abbott Diagnostics Anti-TPO Assay Reagent Recalled Due to Cold Chain Failure
Abbott Diagnostics Anti-TPO assay reagent was recalled after transit delays caused storage outside recommended cold chain conditions, potentially resulting 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 recall of a diagnostic reagent where improper storage could increase the probability of incorrect test results, but no illnesses or injuries have been reported. This meets the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Abbott Diagnostics Anti-TPO assay reagent (Catalog No. 02K4727) is being recalled due to improper storage conditions during transit. Severe thunderstorms caused transportation delays, and certain units were stored outside the manufacturer's recommended temperature ranges for cold chain products.
The recalled product is used for laboratory testing to detect thyroid peroxidase (TPO) antibodies. When stored outside recommended conditions, the assay reagent may degrade, leading to a higher probability of incorrect or delayed test results. Incorrect results could impact the reliability of diagnostic testing and patient care decisions.
The affected product was distributed in the following U.S. states: Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. Customers in these regions should verify their inventory against the provided catalog number and order numbers.
Anyone who has received affected units should discontinue use and contact the manufacturer for replacement products or further guidance on proper handling and return procedures.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- incorrect-test-result
- temperature-excursion
- 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. 02K4727
- GTIN: 380740048327
- Order No. 46048552.
Distribution
Distributed nationwide across the United States.
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