Z-1475-2008

Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system...

Name: Z-1475-2008 Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system...
Creator: Siemens Medical Solutions Diagnostics
Published: 2007-10-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2007-10-17 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions Diagnostics began a recall of Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760 on 2007-10-17. The reason FDA records is "False positive hCG results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1475-2008
Status: Terminated
Initiated: 2007-10-17
Posted: 2008-09-01
Terminated: 2012-03-15
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760
Product code: JHI Visual, Pregnancy Hcg, Prescription Use
Reason for recall: False positive hCG results
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Siemens issued a Service Bulletin to Siemens Healthcare Diagnostics Branches via email on 10/17/007, and a customer bulletin to outside the US . Users are requested to discontinue use and discard the product. A Completion Notification was requested to be completed and returned by the faculties.
Quantity in commerce: 3065 kits
Distribution: Nationwide Canada, France, Korea, Netherlands, UK
Product codes and lots: Lot Number: 97266 Exp. March 12, 2008

Product code JHI

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)