FDA Medical Device Recalls (openFDA)
Diasorin Inc.: Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit
- Recall number
- Z-0673-05
- Recalling firm
- Diasorin Inc.
- Product
- Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit
- Status
- Terminated
- Initiated
- 2004-04-12
- Posted
- 2005-04-06
- Terminated
- 2006-07-22
- Reason
- The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800 reader) was found to be faulty. This program is used to calculate the cut off values for Diastat Anti-Mitochondrial Antibody Kit. Program should include a borderline specification to indicate repeat testing is needed.
- Root cause
- Other
- Action
- A notification letter and effectiveness check form was sent to consignees. This letter recommended that users manually verify results using the specifications outlined in the package insert until a new software version is installed.
- Quantity
- 8
- Distribution
- CA, CT, KS, MA & WA
- Lot, serial or model codes
- Software version 12
- 510(k) numbers
- ["K921183"]
- PMA numbers
- not on file
- Product code
- DBM
- 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