FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Accu-Chek Sensor Comfort Pro blood glucose test strips; International Reference nos. 03758770001, 03360652080, 03051188003, 03620115003, and 04535235003.
- Recall number
- Z-1381-06
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Accu-Chek Sensor Comfort Pro blood glucose test strips; International Reference nos. 03758770001, 03360652080, 03051188003, 03620115003, and 04535235003.
- Status
- Terminated
- Initiated
- 2006-06-27
- Posted
- 2006-08-11
- Terminated
- 2007-05-04
- Reason
- 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
- Root cause
- 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
- 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.
- Lot, serial or model codes
- All lots expiring before July 31, 2007.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LFR
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28