Z-0784-05

Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. 1951 Northwestern...

Name: Z-0784-05 Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. 1951 Northwestern...
Creator: Diasorin Inc.
Published: 2005-03-16
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2005-03-16 / Terminated / root cause: labeling and UDI

FDA source

Diasorin Inc. began a recall of 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... on 2005-03-16. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0784-05
Status: Terminated
Initiated: 2005-03-16
Posted: 2005-04-28
Terminated: 2006-07-22
Recalling firm: Diasorin Inc.
Product: 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.
Product code: LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 14 kits
Distribution: MA, CA, TX, KS, NY, FL
Product codes and lots: lot # 041207T expiration date 9-30-2005

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)