Roche Coaguchex XS Systems for Patient Self-Testing, Roche Diagnostics, Indianapolis, IN; REF 04837738001 includes the R
FDA device recall Z-1594-2009 · posted 2009-08-11 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- The lancet cap may be missing, which could result in an unintended lancet stick to the user.
- Action taken
- 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 Softclix Lancet Hotline at 1-800-778-7057. CoaguChek meter customers: If you have questions regarding the recall, please contact the ACCU-CHEK Softclix Lancet Hotline at 1-800-778-7505.
- Root cause
- Other
- Status
- Terminated
- Product code
- GJS
- Quantity affected
- 449,533 packages of lancets
- Distribution
- Nationwide.
- Date initiated
- 2009-05-13
- Date posted
- 2009-08-11
- Date terminated
- 2011-01-05
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COAGUCHEK XS SYSTEM (K062925) | Roche Diagnostics Corp. | 2007-01-29 |