FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Roche Elecsys total PSA CalSet, catalog number 11731696322.
- Recall number
- Z-0382-06
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Roche Elecsys total PSA CalSet, catalog number 11731696322.
- Status
- Terminated
- Initiated
- 2005-12-07
- Posted
- 2006-01-11
- Terminated
- 2006-02-26
- Reason
- There is the possibility of high results with sera expected to have non-detectable levels of tPSA if these reagent lots are used in combination on the Modular Analytics E170 analyzer.
- Root cause
- Other
- Action
- Consignees were notified of the incompatibility via reagent bulletin dated 12/7/05.
- Quantity
- 25,000 kits
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot 171735.
- 510(k) numbers
- not on file
- PMA numbers
- ["P990056S001"]
- Product code
- LTJ
- 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