Recall Z-1590-2009 ยท FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Roche Diagnostics Corp.
Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Models 3144844001 (10 lancets) and 3583031002 (17 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
This recall record lists no 510(k) number.