The Recall Desk
ModerateFDA (Devices)·Z-1720-2016·Announced 2016-06-01

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.

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 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.
Manufacturer
Accriva Diagnostics Inc., dba ITC, dba Accumetrics
Category
Medical Device — In Vitro Diagnostics
Hazard
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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