FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Roche brand Reflotron GPT (ALT) 30 test strips; catalog # 745138.
- Recall number
- Z-1303-04
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Roche brand Reflotron GPT (ALT) 30 test strips; catalog # 745138.
- Status
- Terminated
- Initiated
- 2004-07-14
- Posted
- 2004-07-31
- Terminated
- 2004-10-14
- Reason
- Coating defect may result is falsely decreased patient and/or control results.
- Root cause
- Other
- Action
- Recall letters dated 7/14/04 were sent to each customer asking that use of these lots be stopped immediately. Testing labs were asked to notify the attending physician for any patients tested with these test strips.
- Quantity
- 197 boxes
- Distribution
- United States.
- Lot, serial or model codes
- Lot 23717132; exp 5/31/2005.
- 510(k) numbers
- ["K864082"]
- PMA numbers
- not on file
- Product code
- CIT
- 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