Recall Z-0513-04 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Diamedix Corporation
Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10, 960 test, For in Vitro Diagnostic Use Lot 71303 Exp. Jun 04 Diamedix, A subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 33127
| Date | Jul 20, 2004 (initiated Dec 9, 2003) |
| Status | Terminated |
| Reason | The test kit may have the potential to give erroneous results in that it may give higher frequency of equivocal/low positive results. |
| Root cause | Other |
| Action | A recall notification letter was mailed to each consignee/user account on 12/9/2003 telling them that the recalled lot may give a higher frequency of equivocal/weak positive results. It requests them to discontinue use and to return the product to them. Also they are asked to sign and date the bottom of the recall letter and fax it back to the recalling firm. |
| Quantity | 8 |
| Distribution | Product was distributed to three hospitals/clinics in AZ, CA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001552 | TREPCHEK TREPONEMAL ANTIBODY EIA Phoenix Biotech Corp., Oct 19, 2000 |