Abbott Diagnostics ARC Anti-TPO Assay Reagent Affected by Transit Delays
Abbott Diagnostics ARC Anti-TPO Assay 100TST B Reagent is being recalled because transit delays due to severe thunderstorms may have caused products to be stored outside recommended temperature conditions, increasing the risk of incorrect or delayed test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The FDA classified this as a Class II recall. The source explicitly states no illnesses or injuries have been reported; the hazard is theoretical (risk of incorrect or delayed test results from temperature excursion). This meets the threshold for a Moderate severity precautionary recall.
Plain-English summary
Abbott Diagnostics ARC Anti-TPO Assay 100TST B Reagent (Catalog No. 02K4727; GTIN: 380740048327) is being recalled nationwide.
The recall was initiated because certain cold chain products experienced transit delays due to severe thunderstorms. These delays may have caused the products to be stored outside the recommended labeled storage conditions.
This storage failure could increase the probability of an incorrect test result or a delayed test result. McKesson Medical-Surgical Inc. is the recalling firm. Healthcare facilities and laboratories that have received affected units should evaluate their products and consider appropriate corrective actions.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B 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. 02K4727
- GTIN: 380740048327
- Order No. 46048552.
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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