Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. 1951 Northwestern Ave, Stillwa
FDA device recall Z-0784-05 · posted 2005-04-28 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- Reason for recall
- Package insert incorrectly states that specimen diluent is ready to use, however specimen diluent bottle in kit states that the diluent must be diluted to one liter.
- Action taken
- Customers were contacted via telephone, informed of the incorrect package insert, asked to destroy any incorrect inserts and a correct insert was faxed to customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- LIP
- Quantity affected
- 14 kits
- Distribution
- MA, CA, TX, KS, NY, FL
- Date initiated
- 2005-03-16
- Date posted
- 2005-04-28
- 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 |
|---|---|---|
| TREPCHEK TREPONEMAL ANTIBODY EIA (K001552) | Phoenix Biotech Corp. | 2000-10-19 |