Abbott Diagnostics ARC T-Uptake Assay Reagent Recalled for Storage Excursion
Abbott Diagnostics ARC T-Uptake Assay reagent is being recalled because severe thunderstorms caused certain units to be stored outside recommended temperature conditions, which may 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 recall involving a diagnostic reagent where storage excursion creates risk of incorrect or delayed test results, which could lead to harm in clinical decision-making. No illnesses or injuries are reported, but the risk-of-harm nature and diagnostic function warrant a High severity rating.
Plain-English summary
The Abbott Diagnostics ARC T-Uptake Assay (100TST/BX) reagent, manufactured by Mckesson Medical-Surgical Inc. Corporate Office, is being recalled due to transit delays caused by severe thunderstorms. During these delays, certain cold chain products were stored outside their recommended labeled storage conditions.
This storage excursion failure could increase the probability of an incorrect test result or a delayed test result. The affected product has Catalog No. 02K4825, GTIN 380740003517, and Order No. 46061983.
The product was distributed nationwide in the following states: Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. Customers who have received this product should contact their healthcare provider or Mckesson Medical-Surgical Inc. for guidance on whether their units were affected and what actions to take.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- storage-excursion
- test-result-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. 02K4825
- GTIN: 380740003517
- Order No. 46061983.
Distribution
Distributed nationwide across the United States.
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