Recall Z-0325-05 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Diamedix Corporation
The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay for the qualitative detection of Treponema pallidum IgG antibodies in human serum or plasma. The reagents can be used either manually or in conjunction with the MAGO Plus or APTUS Automated EIA Processors. The FDA has not cleared this product for use in screening blood or plasma donors. The kit is labeled with a
| Date | Dec 17, 2004 (initiated Sep 11, 2003) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 490 kits |
| Distribution | Distributed to 54 laboratory accounts throughout the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001552 | TREPCHEK TREPONEMAL ANTIBODY EIA Phoenix Biotech Corp., Oct 19, 2000 |