The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay for the qualitative detection of T
FDA device recall Z-0325-05 · posted 2004-12-17 · Terminated
Recall details
- Recalling firm
- Diamedix Corporation
- Reason for recall
- Several customers complained that either the negative control index value exceeded the upper control limit or there was very low activity of the cut off calibrator causing patient sample test runs to be called invalid.
- Action taken
- Recall letter dated 10/8/03 was sent, via FEDEX, with replacement conjugate bottles to those accounts reporting remaining stock.The letter requested that the original conjugate bottle, lot number 42023 be discarded and replaced with new conjugate lot #71323z. The letter also included a new inner box label that had the lot number information for the new conjugate bottle.
- Root cause
- Other
- Status
- Terminated
- Product code
- LIP
- Quantity affected
- 490 kits
- Distribution
- Distributed to 54 laboratory accounts throughout the US.
- Date initiated
- 2003-09-11
- Date posted
- 2004-12-17
- Date terminated
- 2009-10-05
- Location
- Miami, FL
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 |