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.
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: 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
- Hazard
- temperature-excursion
- test-result-accuracy
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.
Related recalls
Same category
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22