FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Accu-Chek Advantage Plus blood glucose test strips; Reference number 04735102001 (All sold outside of the United States).
- Recall number
- Z-0569-06
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Accu-Chek Advantage Plus blood glucose test strips; Reference number 04735102001 (All sold outside of the United States).
- Status
- Terminated
- Initiated
- 2006-02-10
- Posted
- 2006-02-28
- Terminated
- 2007-02-08
- Reason
- There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings.
- Root cause
- Other
- Action
- Notifications (letters) dated 2/10/06 were sent to healthcare professionals, retail pharmacies, hospitals and mail order firms asking them to provide their customers with information instructing the users to inspect their strip vials and to not use strips from defective vials. Mail order accounts were instructed to forward the recall notification to end users.
- Quantity
- not on file
- Distribution
- Nationwide, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, England, France, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan and Thailand.
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- ["K982089"]
- 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