Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin AN
FDA device recall Z-0807-05 · posted 2005-05-10 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- Reason for recall
- 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.
- Action taken
- 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
- Root cause
- Other
- Status
- Terminated
- Product code
- DHN
- Quantity affected
- 13
- Distribution
- OH, NJ, KY, TX, NC, FL, VA, WA, AL, CO, MO, AZ , CA , CT & NV
- Date initiated
- 2004-09-24
- Date posted
- 2005-05-10
- Date terminated
- 2006-07-22
- Location
- Stillwater, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANA HEP-2 FLUORO-KIT (K822397) | Clinical Sciences, Inc. | 1982-09-21 |