—#46695

Product

Accu-Chek Comfort Curve blood glucose test strips; (packaged in 10s, 50s, and/or 100s) U.S. Reference nos. 12030420001, 12030373001, 12030381001, 12030365001, 04388208001, 04388186001 and 03000141001.

FDA product code: LFR — Glucose Dehydrogenase, Glucose
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K010362
Affected lot / code info: All lots expiring before July 31, 2007.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2006-06-27
Posted by FDA: 2006-08-11
Terminated: 2007-05-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #46695. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.