Recall Z-0784-05 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Diasorin Inc.
Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. 1951 Northwestern Ave, Stillwater, MN 55082-0285 USA. Manufactured by Phoenix Bio-Tech Corp., 6910 Kitimat Road, Unit #1, Mississauga, Ontario, Canada L5N 5M2.
| Date | Apr 28, 2005 (initiated Mar 16, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 14 kits |
| Distribution | MA, CA, TX, KS, NY, FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001552 | TREPCHEK TREPONEMAL ANTIBODY EIA Phoenix Biotech Corp., Oct 19, 2000 |