| Class 2 Device Recall Roche ACCUCHEK Performa blood glucose meter | |
Date Initiated by Firm | June 10, 2009 |
Date Posted | September 16, 2009 |
Recall Status1 |
Terminated 3 on October 29, 2010 |
Recall Number | Z-2006-2009 |
Recall Event ID |
52449 |
510(K)Number | K070585 |
Product Classification |
System, test, blood glucose - Product Code NBW
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Product | Roche ACCU-CHEK Performa blood glucose meters/kits, Roche Diagnostics, Indianapolis, IN.
Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as well as in heparin (lithium or sodium) or EDTA anticoagulated venous blood. |
Code Information |
All Lots with REF Numbers: 4861574019, 4861574020, 4861582014, 4861582019, 4861582020, 4861582034, 4862015023, 4862015027 and 4929381023. |
Recalling Firm/ Manufacturer |
Roche Diagnostics Corp. 9115 Hague Rd Indianapolis IN 46256-1025
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For Additional Information Contact | 317-521-7252 |
Manufacturer Reason for Recall | There may be a significant negative bias when testing neonate samples. |
FDA Determined Cause 2 | Process control |
Action | Roche Diagnostics notified consignees in the affected countries of the problem by "Urgent Field Safety Notice" dated June 10, 2009 and instructed to cease using the Accu-Chek Performa and Accu-Chek Inform II systems on neonates, except for systems using test strips with advanced chemistry.
For questions and additional information, contact your local Roche Diagnostics sales affiliate or sales representative. |
Quantity in Commerce | 1,518 of total products |
Distribution | International Distribution -- Argentina, Australia, Brazil, Chili, China, Colombia, Ecuador, France, Germany, Great Britain, Hong Kong, India, Korea, Malaysia, Mexico, New Zealand, Pakistan, Panama, Peru, Philippines, Singapore, South Africa, Taiwan, Thailand, Uruguay and Venezuela. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = NBW
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