—#82207

Product

Roche ACCU-CHEK Compact Plus Meter Kit, Roche Diagnostics, Indianapolis, IN; REFS 03149137001, 05177294001 and 05079241001 include the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model 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.

FDA product code: LFR — Glucose Dehydrogenase, Glucose
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K040796
Affected lot / code info: REF 03149137001; lots 116137, 116148, 116151, 116157, 116180, 116194, 116199, 116216, 116224 and 116234. REF 05177294001; lots 116142, 116158 and 116204. REF 05079241001; lots 116134, 116141, 116149, 116164, 116170, 116171, 116188, 116191, 116202, 116207, 116212, 116217, 116221, 116231 and 116236. Lancet Model 3583031002; lots M25C9, M25D2, M27D6, M32A8 and M32B3.

Why it was recalled

The lancet cap may be missing, which could result in an unintended lancet stick to the user.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2009-05-13
Posted by FDA: 2009-08-11
Terminated: 2011-01-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82207. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.