Recalls / —
—#82198
Product
Roche ACCU-Chek Aviva Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 04893247001 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.
- FDA product code
- LFR — Glucose Dehydrogenase, Glucose
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K060620
- Affected lot / code info
- REF 04893247001; lots 122136, 122137, 122143, 122155, 122179, 122187, 122196, 122198, 122213, 122224 and 122236. Lancet Model 3144844001; lots M25C2, M25C5, M25C7, N32A5 and M32B5.
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 #82198. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.