FDA Medical Device Recalls (openFDA)
Diasorin Inc.: Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin ANAFLUOR Indirect Fluorescent Antibody Test.
- Recall number
- Z-0807-05
- Recalling firm
- Diasorin Inc.
- Product
- Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin ANAFLUOR Indirect Fluorescent Antibody Test.
- Status
- Terminated
- Initiated
- 2004-09-24
- Posted
- 2005-05-10
- Terminated
- 2006-07-22
- Reason
- A problem with software for the PolyTiter Immunofluorescent Titration System in that no flags or warnings appear when PolyTiter Calibrator Values are re-entered or changed (including values changed to unacceptable values) after the initial curve has been generated, if the 'refresh button' has not been pressed. The graph may appear valid; however erroneous results may occur.
- Root cause
- Other
- Action
- Customers were sent a Technical Bulletin describing the correct procedure to be used when entering data into the Poly/Titer tiration system, until the updated software is installed
- Quantity
- 13
- Distribution
- OH, NJ, KY, TX, NC, FL, VA, WA, AL, CO, MO, AZ , CA , CT & NV
- Lot, serial or model codes
- all versions of software
- 510(k) numbers
- ["K822397"]
- PMA numbers
- not on file
- Product code
- DHN
- 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