Recall Z-1720-2016— Accriva Diagnostics Inc., dba ITC, dba Accumetrics

Name: FDA recall Z-1720-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-22

Class II · Terminated

Class II FDA medical device recall by Accriva Diagnostics Inc., dba ITC, dba Accumetrics, initiated 2016-04-22, terminated 2016-12-14. It names one FDA 510(k) clearance: K940401. Product: Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.. 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..

Recalling firm: Accriva Diagnostics Inc., dba ITC, dba Accumetrics
Classification: Class II
Status: Terminated
Initiated: 2016-04-22
Terminated: 2016-12-14
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K940401 — JR. MICROCOAGULATION SYSTEMInternational Technidyne Corp.·cleared 1994-05-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.