Z-0513-04

Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10, 960 test, For in Vitro...

Name: Z-0513-04 Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10, 960 test, For in Vitro...
Creator: Diamedix Corporation
Published: 2003-12-09
License: https://open.fda.gov/license/

Diamedix Corp. / initiated 2003-12-09 / Terminated

FDA source

Diamedix Corporation began a recall of 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... on 2003-12-09. The reason FDA records is "The test kit may have the potential to give erroneous results in that it may give higher frequency of equivocal/low positive results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0513-04
Status: Terminated
Initiated: 2003-12-09
Posted: 2004-07-20
Terminated: 2008-11-20
Recalling firm: Diamedix Corp.
Product: 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
Product code: LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
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.
FDA 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 in commerce: 8
Distribution: Product was distributed to three hospitals/clinics in AZ, CA and TX.
Product codes and lots: Lot Number 71303, expiration date June 2004

Product code LIP

K001552Class IITrepchek Treponemal Antibody EiaPhoenix Biotech Corp. / cleared 2000-10-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)