Roche ACCU-Chek Voicemate Meter, Roche Diagnostics, Indianapolis, IN; REF 12030802001 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.
This recall has been terminated (originally issued August 11, 2009).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- May 13, 2009
- Posted
- August 11, 2009
- Terminated
- January 5, 2011
- Recall Number
- Z-1592-2009
- Quantity
- 449,533 packages of lancets
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The lancet cap may be missing, which could result in an unintended lancet stick to the user.
Distribution
Nationwide.
Lot / Code Info
REF 12030802001; lot 550594A. Lancet Model 3144844001; lots M25C2, M25C5, M25C7, N32A5 and M32B5.
Root 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.