PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titration System, DiaSorin part # PT
FDA device recall Z-0676-05 · posted 2005-04-06 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- Reason for recall
- The program for a specific immunofluorescent titration system (Polymedco PolyTiter immunofluorescent Titration System) was found faulty in that the calibrator 2 value was incorrectly programmed as 1:120 instead of 1:160.
- Action taken
- All customers were notified of the problem via phone and letter. Verbal instructions were given of how to change the Calibrator 2 titer to the correct one. A letter instructs customer to return software disc to DiaSorin, remove version 2.8 from the computer and install version 2.8.1.
- Root cause
- Other
- Status
- Terminated
- Product code
- DHN
- Quantity affected
- 14
- Distribution
- AL, AZ, CA, CO, FL, KY, MO, NC, NJ, NV, OH, TX, & VA
- Date initiated
- 2004-06-30
- Date posted
- 2005-04-06
- Date terminated
- 2006-07-22
- Location
- Stillwater, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANA HEP-2 FLUORO-KIT (K822397) | Clinical Sciences, Inc. | 1982-09-21 |