Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10, 960 test, For in Vitro Diagnostic Use Lo
FDA device recall Z-0513-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Diamedix Corporation
- Reason for recall
- The test kit may have the potential to give erroneous results in that it may give higher frequency of equivocal/low positive results.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LIP
- Quantity affected
- 8
- Distribution
- Product was distributed to three hospitals/clinics in AZ, CA and TX.
- Date initiated
- 2003-12-09
- Date posted
- 2004-07-20
- Date terminated
- 2008-11-20
- 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 |