FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: BioTek brand Automated Microplate Reader; model ELx808, Roche catalog number 03145387001.
- Recall number
- Z-0574-05
- Recalling firm
- Roche Diagnostics Corp.
- Product
- BioTek brand Automated Microplate Reader; model ELx808, Roche catalog number 03145387001.
- Status
- Terminated
- Initiated
- 2005-02-15
- Posted
- 2005-03-08
- Terminated
- 2006-05-10
- Reason
- The parameters loaded in the analyzer for the hepatitis C virus do not match those in the package insert, and patient results may be reported out as false positives or false negatives.
- Root cause
- Other
- Action
- Recall letters dated 2/15/05 are being sent to each consignee instructing them to discontinue use of pre-programmed HCV parameters with the Amplicor heatitis C virus test and that previous test results within a specific range be reviewed by a physician.
- Quantity
- not on file
- Distribution
- Nationwide and Canada.
- Lot, serial or model codes
- All serial numbers pre-programmed with HCV singlet and HCV duplicate parameters by Roche for use with the Roche HCV test version 2.0.
- 510(k) numbers
- ["K953710"]
- PMA numbers
- not on file
- Product code
- JJQ
- 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