Abbott Recalls Architect HAVAB G Reagent Kits Due to Antigen Concentration Error
Abbott is recalling 7,347 Architect HAVAB G Reagent Kits because an erroneous concentration value was used during manufacture, resulting in a decreased amount of antigen.
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 recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Abbott GmbH & Co. KG is recalling 7,347 units of the ARCHITECT HAVAB G Reagent Kit, List Number 6L27 25. The affected lots are 03429BE00, 06172BE00, 08073BE00, and 10353BE00. These products were distributed nationwide in the United States, including Puerto Rico.
The recall was initiated because an erroneous concentration value for hepatitis A virus was utilized during the manufacturing process. This error led to a decreased amount of antigen being used in the impacted lots. The agency has classified this recall as Class II.
Healthcare facilities and consumers should stop using the affected reagent kits and contact Abbott for further instructions or a replacement. The specific UDI codes for the affected lots are provided in the official recall documentation.
The recalled product
- Product
- ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
- Manufacturer
- Abbott Gmbh & Co. KG
- Affected units
- 7,347
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 (7)
- List Number 6L27 25. Lot No: 03429BE00
- 06172BE00
- 08073BE00
- 10353BE00. UDI: (01)00380740011185 (17)200320(10)03429BE00
- (01)00380740011185 (17)200604(10)06172BE00
- (01)00380740011185 (17)200819(10)08073BE00
- (01)00380740011185 (17)201023(10)10353BE00.
Distribution
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