Z-0542-05

RAPID SYPHILIS TEST KIT, per insert, contents of the kit are: 1 Rapid Syphilis test cassette, 1 alcohol swab...

Name: Z-0542-05 RAPID SYPHILIS TEST KIT, per insert, contents of the kit are: 1 Rapid Syphilis test cassette, 1 alcohol swab...
Creator: Ups Supply Chain Solutions
Published: 2005-02-04
License: https://open.fda.gov/license/

UPS Supply Chain Solutions, Inc. / initiated 2005-02-04 / Terminated

FDA source

Ups Supply Chain Solutions began a recall of RAPID SYPHILIS TEST KIT, per insert, contents of the kit are: 1 Rapid Syphilis test cassette, 1 alcohol swab, 1 buffer container, 1 lancet (needle), 1 zipped... on 2005-02-04. The reason FDA records is "The kits are not approved for use in the United States". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0542-05
Status: Terminated
Initiated: 2005-02-04
Posted: 2005-02-15
Terminated: 2005-07-27
Recalling firm: UPS Supply Chain Solutions, Inc.
Product: RAPID SYPHILIS TEST KIT, per insert, contents of the kit are: 1 Rapid Syphilis test cassette, 1 alcohol swab, 1 buffer container, 1 lancet (needle), 1 zipped bag, 1 pipette (plastic) (included with cassette). There is no firm identified on the product packaging.
Reason for recall: The kits are not approved for use in the United States.
FDA root cause: Other
Action: Letters dated February 4, 2005, flagged 'Important Safety Notice -- Test Kit Recall' with instructions to consumers to destroy kits and to consult a health care professional if they have used the test kit. Letters will require a signed receipt. Letterhead used identifies recalling firm as 'FDTS'.
Quantity in commerce: 75 kits
Distribution: Consumers throughout the United States.
Product codes and lots: All lots are subject to recall.

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)