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Recall Observatory FDA recall evidence

Device product

Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.

Z-1720-2016

April 22, 2016

Class II

Product summary

Firm
Accriva Diagnostics Inc., dba ITC, dba Accumetrics
Event
Event 73949
Status
Terminated
Classification
Class II
Quantity
135 boxes
Official record key
device-enforcement:Z-1720-2016

Official wording

Reason: Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result.

Code information: Lot #B6JCA012

Distribution pattern: U.S. distribution to the following; state: VA. Foreign distribution to the following; China, Italy, Germany.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result.