FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Accu-Chek Advantage glucose test strips; part numbers 336, 556, 787 and 966.
- Recall number
- Z-0716-03
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Accu-Chek Advantage glucose test strips; part numbers 336, 556, 787 and 966.
- Status
- Terminated
- Initiated
- 2003-02-12
- Posted
- 2003-04-09
- Terminated
- 2003-09-15
- Reason
- Crack in the bottom of the test strip vial will cause erroneously low or high blood glucose readings.
- Root cause
- Other
- Action
- Urgent Product Correction letters dated 2/12/03 were issued to pharmacists, specific health care providers, and the laboratory manager at customer accounts. Letter recipients were asked to advise their patients to inspect their vial for a crack prior to each use.
- Quantity
- not on file
- Distribution
- United States, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Guatemala, Honduras, Hong Kong, Indonesia, Japan, Malaysia, Mexico, New Zealand, Norway, Pakistan, Peru, Philippines, Portugal, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, United Kingdom and Vietnam.
- 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