Recall Z-1720-2016 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Accriva Diagnostics Inc., dba ITC, dba Accumetrics
Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
| Date | Apr 22, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Process design |
| Action | Accriva sent an " Urgent Field Safety Notice" letter dated April 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to take the following actions: 1. Forward communication to all those within organization who need to be aware of this matter. In addition, forward notification to all other organizations where affected devices may have been transferred to. 2. Check inventory to determine if you have any APTT Test Cuvettes, Lot Number: B6JCA012 3. If have inventory of APTT Test Cuvet |
| Quantity | 135 boxes |
| Distribution | U.S. distribution to the following; state: VA. Foreign distribution to the following; China, Italy, Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K940401 | JR. MICROCOAGULATION SYSTEM International Technidyne Corp., May 11, 1994 |