Recall Z-1591-2009
Roche Diagnostics Corp. · initiated May 13, 2009
Product
Roche ACCU-Chek Active Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 03184501001 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.
Codes / lots: REF 03184501001; lots 116099, 116109, 116122, 116135, 116145, 116146, 116155, 116167, 116185, 116190, 116192, 116205, 116209, 116215, 116229, 116230 and 116237. Lancet Model 3144844001; lots M25C2, M25C5, M25C7, N32A5 and M32B5.
Reason for recall
The lancet cap may be missing, which could result in an unintended lancet stick to the user.
FDA-determined cause: Other
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.
Details
- Recall number
- Z-1591-2009
- Initiated
- May 13, 2009
- Posted by FDA
- August 11, 2009
- Terminated
- January 5, 2011
- Product code
- LFR – Glucose Dehydrogenase, Glucose
- Quantity
- 449,533 packages of lancets
- Distribution
- Nationwide.
- Recalling firm
- Roche Diagnostics Corp., Indianapolis, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1590-2009 | Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis…The lancet cap may be missing, which could result in an unintended lancet stick to the user. | 05/13/2009Terminated |
| Z-1592-2009 | Roche ACCU-Chek Voicemate Meter, Roche Diagnostics, Indianapolis, IN; REF 12030802001…The lancet cap may be missing, which could result in an unintended lancet stick to the user. | 05/13/2009Terminated |
| Z-1593-2009 | Roche ACCU-Chek Aviva Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 04893247001…The lancet cap may be missing, which could result in an unintended lancet stick to the user. | 05/13/2009Terminated |
| Z-1594-2009 | Roche Coaguchex XS Systems for Patient Self-Testing, Roche Diagnostics, Indianapolis…The lancet cap may be missing, which could result in an unintended lancet stick to the user. | 05/13/2009Terminated |
| Z-1595-2009 | Roche ACCU-CHEK Compact Plus Meter Kit, Roche Diagnostics, Indianapolis, IN; REFS…The lancet cap may be missing, which could result in an unintended lancet stick to the user. | 05/13/2009Terminated |