Accu-Chek Advantage blood glucose test strips; U.S. Reference nos. (packaged in 50s and/or 100s) 03144917001, 0314470400
FDA device recall Z-1378-06 · posted 2006-08-11 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- 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
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LFR
- Quantity affected
- 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 Z
- Date initiated
- 2006-06-27
- Date posted
- 2006-08-11
- Date terminated
- 2007-05-04
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS (K982089) | Boehringer Mannheim Corp. | 1998-09-03 |