Accriva APTT Cuvettes Recalled Due to Mis-positioned Reagent
Accriva Diagnostics is recalling APTT Cuvettes for the Hemochron Jr. system because the clot activating reagent may be mis-positioned or absent, causing test errors or high 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 recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity recall involving a defect that affects test accuracy.
Plain-English summary
Accriva Diagnostics Inc. is recalling 135 boxes of Accriva APTT Cuvettes (catalog #J103, lot B6JCA012) intended for use on the Hemochron Jr. test system. The recall was initiated because the clot activating reagent may be mis-positioned or visibly absent in the cuvette's test channel.
This defect can cause the APTT test to display an error code or produce an erroneously high result. The affected products were distributed in the United States to Virginia and internationally to China, Italy, and Germany.
Users of these products should stop using the affected lot and contact the manufacturer for further instructions.
The recalled product
- Product
- Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
- Affected units
- 135
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 (1)
- Lot #B6JCA012
Distribution
Distributed in 1 state:
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