Accu-Chek Sensor Comfort Pro blood glucose test strips; International Reference nos. 03758770001, 03360652080, 030511880

FDA device recall Z-1381-06 · 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 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