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U.S. Department of Health and Human Services

Class 2 Device Recall Roche ACCUChek Coaguchex XS Systems for Patient SelfTesting

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  Class 2 Device Recall Roche ACCUChek Coaguchex XS Systems for Patient SelfTesting see related information
Date Initiated by Firm May 13, 2009
Date Posted August 11, 2009
Recall Status1 Terminated 3 on January 05, 2011
Recall Number Z-1595-2009
Recall Event ID 51963
510(K)Number K040796  
Product Classification Glucose dehydrogenase, glucose - Product Code LFR
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
800-778-7057
Manufacturer Reason
for Recall		 The lancet cap may be missing, which could result in an unintended lancet stick to the user.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 449,533 packages of lancets
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LFR and Original Applicant = ROCHE DIAGNOSTICS CORP.
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