Recall Z-1582-2013 ยท GJS Test, Time, Prothrombin
Roche Diagnostics Operations, Inc.
CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (non anticoagulated venous whole blood).
| Date | Jun 24, 2013 (initiated May 16, 2013) |
| Status | Terminated |
| Reason | Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed. |
| Root cause | Software design |
| Action | Rochet sent an Urgent Medical Device Correction letter dated May 16, 2013, via UPS Ground to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were issued the following instructions: If you are using Warfarin therapy in combination with antibiotics and/or chemotherapy drugs, which could potentially lead to an extremely high test result (> 10 INR), you may in rare cases receive repeated ERROR 6 messages instead of a test result. If the ERROR 6 message is displayed repeatedly on your CoaguChek XS meter, immediately |
| Quantity | 537 meters total |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093460 | COAGUCHEK XS PRO SYSTEM Roche Diagnostics, Mar 18, 2010 |