| Class 2 Device Recall ACCUCHEK | |
Date Initiated by Firm | June 27, 2006 |
Date Posted | August 11, 2006 |
Recall Status1 |
Terminated 3 on May 04, 2007 |
Recall Number | Z-1384-06 |
Recall Event ID |
35729 |
Product Classification |
blood glucose test strips; - Product Code LFR
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Product | Accu-Chek Inform blood glucose test strips; International Reference nos. 04535057001, 04647696001 and 04535120001. |
Code Information |
All lots expiring before July 31, 2007. |
Recalling Firm/ Manufacturer |
Roche Diagnostics Corp. 9115 Hague Rd Indianapolis IN 46256-1025
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For Additional Information Contact | 800-858-8072 |
Manufacturer Reason for Recall | The drying agent beads, located in the cap, may become loose and fall into the vial causing the test strips to potentially give incorrect blood glucose test results |
FDA Determined Cause 2 | Other |
Action | U.S. consignees, point of care coordinators or laboratory managers, long term care professionals, health care professionals, pharmacists, and mail order distributors were notified via letter dated 6/28/06 to cease using the strips and to contact the firm for replacement if they see loose beads in their vial. International accounts were also notified. |
Quantity in Commerce | 21,000,000 consumer vials and 10,000,000 hospital vials to U.S. plus 35,000,000 vials international-(Totals for Recalls Z-1377-1384-06) |
Distribution | Worldwide Distribution-USA and countries of Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, England, France, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, New Zealand, Pakistan, Paraguay, Peru, Philippines, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand and Uruguay. |
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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