FDA Medical Device Recalls (openFDA)
Diasorin Inc.: Software written for a specific automated microtiter plate instrument, Bio-Tek ELx800 reader for use with the ENA 6 Screen ELISA kit assay.
- Recall number
- Z-0672-05
- Recalling firm
- Diasorin Inc.
- Product
- Software written for a specific automated microtiter plate instrument, Bio-Tek ELx800 reader for use with the ENA 6 Screen ELISA kit assay.
- Status
- Terminated
- Initiated
- 2004-04-20
- Posted
- 2005-04-06
- Terminated
- 2006-07-22
- Reason
- An error in the Bio-Tek ELx800 microplate reader programming specifications for the ENA screen Assay exists in that an equivocal (borderline) zone is missing.
- Root cause
- Other
- Action
- Customers were sent a notification letter informing customers of an error in the Bio-Tek ELx800 programming specifications. Customers were asked to repeat testing for historical runs for RSLT (S/CO) that read from 0.95 to 1.0. A response form is asked to be faxed back to DiaSorin.
- Quantity
- 29
- Distribution
- CT, FL, NY, WA, TX, AR, TN, CANADA
- Lot, serial or model codes
- software versions 9 thru 12
- 510(k) numbers
- ["K944505"]
- PMA numbers
- not on file
- Product code
- LLL
- 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