FDA Medical Device Recalls (openFDA)
Roche Molecular Systems Inc: COBAS TaqMan analyzer, Series 96; catalog number 8080216.
- Recall number
- Z-0917-03
- Recalling firm
- Roche Molecular Systems Inc
- Product
- COBAS TaqMan analyzer, Series 96; catalog number 8080216.
- Status
- Terminated
- Initiated
- 2003-03-06
- Posted
- 2003-06-05
- Terminated
- 2003-12-10
- Reason
- A false positive result may be reported.
- Root cause
- Other
- Action
- Each customer was informed of the recall by telephone on March 6, 2003. Customers were instructed to check each postiive result to see if the 'RFITOOLOW' flag was generated, and follow-up instructions were provided. A recall letter was also faxed and mailed to each customer on March 6, 2003.
- Quantity
- 16
- Distribution
- Nationwide. California, Colorado, Georgia, Illinois, Maryland, Missouri, New Jersey, New Mexico, North Carolina, Utah and Virginia.
- Lot, serial or model codes
- All units with software versions TaqLink v 1.0 or TaqLink v 1.1.
- 510(k) numbers
- ["K012966"]
- PMA numbers
- not on file
- Product code
- JJF
- Firm FEI
- 1000121742
- Firm city
- Belleville
- Firm state
- NJ
- 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