FDA Medical Device Recalls (openFDA)
Diasorin Inc.: Version 12 software program written for the Bio-Tek ELx800 automated microtiter plate reader with use of PRO-Trac Tacrolimus ELISA kit
- Recall number
- Z-0702-05
- Recalling firm
- Diasorin Inc.
- Product
- Version 12 software program written for the Bio-Tek ELx800 automated microtiter plate reader with use of PRO-Trac Tacrolimus ELISA kit
- Status
- Terminated
- Initiated
- 2004-04-12
- Posted
- 2005-04-13
- Terminated
- 2006-07-22
- Reason
- The software program written for use in the automated microtiter plate reader (Bio-Tek ELx800) for use with the Pro-Trac II Tacrolimus ELISA kit was found to be faulty. Assay software program did not include the Calibrator Zero OD specification (STDO>=1.500) as specified in the product insert.
- Root cause
- Other
- Action
- Customers were sent notification letters and effectiveness check form. recommended users manually veify results using product insert specifications.
- Quantity
- not on file
- Distribution
- CA, Washington DC, FL, KY & Canada
- Lot, serial or model codes
- version 12
- 510(k) numbers
- not on file
- PMA numbers
- ["P970025"]
- Product code
- MLM
- Firm FEI
- 2182595
- Firm city
- Stillwater
- Firm state
- MN
- 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