FDA Medical Device Recalls (openFDA)
Diasorin Inc.: ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System.
- Recall number
- Z-1576-05
- Recalling firm
- Diasorin Inc.
- Product
- ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System.
- Status
- Terminated
- Initiated
- 2004-03-09
- Posted
- 2005-10-01
- Terminated
- 2006-07-22
- Reason
- An error in the acceptance specification for the substrate blank optical density was discovered in the Bio-Tek ELx800 programming specifications for the ORTHO HCV Version 3.0 ELISA Test System Assay.
- Root cause
- Other
- Action
- Dear Customer letters, dated 03/08/2004 were sent to customers informing them of the specification error and instructing users to validate their assays manually.
- Quantity
- 128
- Distribution
- AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WI & WV
- Lot, serial or model codes
- version 12 and older software
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MZO
- 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