Abbott Diagnostics ARC T-Uptake Assay Recalled Due to Storage Condition Deviation
Abbott Diagnostics ARC T-Uptake Assay units may have been stored outside recommended temperature conditions during transit delays caused by severe thunderstorms. Storage deviation could result in 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: FDA Class II medical device recall with no reported test failures, injuries, or illnesses. The hazard is theoretical and conditional—storage exposure may increase the probability of incorrect or delayed results—warranting precautionary action without exceeding Moderate severity.
Plain-English summary
Abbott Diagnostics ARC T-Uptake Assay (100TST/BX) is a diagnostic reagent used for thyroid function testing. Two units of this product are being recalled.
During transit, the affected units experienced delays due to severe thunderstorms. Consequently, these products may have been stored outside the manufacturer's recommended labeled storage conditions. Storage outside these conditions could increase the probability of an incorrect test result or a delayed test result.
The recalled product has been distributed nationwide to Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. The affected product is identified by Catalog No. 02K4825, GTIN 380740003517, and Order No. 46061983.
Healthcare providers and facilities that received the recalled product should evaluate affected test results and consider repeat testing if clinically indicated. Questions regarding the recalled product should be directed to Mckesson Medical-Surgical Inc., the recalling firm.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- incorrect-test-result
- delayed-test-result
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. 02K4825
- GTIN: 380740003517
- Order No. 46061983.
Distribution
Distributed nationwide across the United States.
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