Recall Z-1594-2009 ยท GJS Test, Time, Prothrombin
Roche Diagnostics Corp.
Roche Coaguchex XS Systems for Patient Self-Testing, Roche Diagnostics, Indianapolis, IN; REF 04837738001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model 3144844001 (10 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing.
| Date | Aug 11, 2009 (initiated May 13, 2009) |
| Status | Terminated |
| Reason | The lancet cap may be missing, which could result in an unintended lancet stick to the user. |
| Root cause | Other |
| Action | An "Urgent Medical Device Correction" letter dated May 13, 2009 was sent to all affected customers, distributors and consumer consignees who have either registered their blood glucose meter, contacted the firm about the lancets since 10/1/08, or have been shipped lancets by Roche since 10/1/08 were notified of the problem. Distributors were requested to notify each patient self-tester to whom a meter kit was distributed since October 1, 2008. The firm issued a press release on May 18, 2009. Diabetes Care customers: If you have questions regarding the recall, please contact the ACCU-CHEK S |
| Quantity | 449,533 packages of lancets |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062925 | COAGUCHEK XS SYSTEM Roche Diagnostics Corp., Jan 29, 2007 |