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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
Model 3144844001, lots M25C2, M25C5, M25C7, N32A5 and M32B5. Model 3583031002, lots M25C9, M25D2, M27D6, M32A8 and M32B3.
Products Sold
Model 3144844001; lots M25C2, M25C5, M25C7, N32A5 and M32B5. Model 3583031002; lots M25C9, M25D2, M27D6, M32A8 and M32B3.
Roche Diagnostics Corp. is recalling Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Models due to The lancet cap may be missing, which could result in an unintended lancet stick to the user.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The lancet cap may be missing, which could result in an unintended lancet stick to the user.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026