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U.S. Department of Health and Human Services

Class 2 Device Recall ACCUCHEK

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 Class 2 Device Recall ACCUCHEKsee related information
Date Initiated by FirmJune 27, 2006
Date PostedAugust 11, 2006
Recall Status1 Terminated 3 on May 04, 2007
Recall NumberZ-1381-06
Recall Event ID 35729
Product Classification blood glucose test strips; - Product Code LFR
ProductAccu-Chek Sensor Comfort Pro blood glucose test strips; International Reference nos. 03758770001, 03360652080, 03051188003, 03620115003, and 04535235003.
Code Information All lots expiring before July 31, 2007.
Recalling Firm/
Manufacturer		 Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
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 results
FDA Determined
Cause 2		Other
ActionU.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 Commerce21,000,000 consumer vials and 10,000,000 hospital vials to U.S. plus 35,000,000 vials international-(Totals for Recalls Z-1377-1384-06)
DistributionWorldwide 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 CycleTPLC 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.
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