Z-0972-2012

Siemens CLINITEST hCG -Pregnancy Test (qualitative), Radio immunoassay,Human Chorionic Gonadotropin (hCG)...

Name: Z-0972-2012 Siemens CLINITEST hCG -Pregnancy Test (qualitative), Radio immunoassay,Human Chorionic Gonadotropin (hCG)...
Creator: Siemens Healthcare Diagnostics
Published: 2011-12-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-12-15 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics began a recall of Siemens CLINITEST hCG -Pregnancy Test (qualitative), Radio immunoassay,Human Chorionic Gonadotropin (hCG) test system. Package of 25. Product Code 1760/... on 2011-12-15. The reason FDA records is "A potential for false positive or increase in borderline results with patients and commercially available negative control material". 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-0972-2012
Status: Terminated
Initiated: 2011-12-15
Posted: 2012-02-07
Terminated: 2015-03-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens CLINITEST hCG -Pregnancy Test (qualitative), Radio immunoassay,Human Chorionic Gonadotropin (hCG) test system. Package of 25. Product Code 1760/ Catalog# 06484105). For in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens.
Product code: JHI Visual, Pregnancy Hcg, Prescription Use
Reason for recall: A potential for false positive or increase in borderline results with patients and commercially available negative control material.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Siemens issued Overnight Mailings of Urgent: Recall Notices on December 15, 2011 for delivery beginning December 16, 2011 to Distributors and end users. Customer bulletin has been issued instructing customers to discontinue use of product and discard impacted inventory. Customers are to contact their distributor regarding credit for unused product. For technical questions contact Siemens Technical Solutions Center at 877-229-3711.
Quantity in commerce: 48,578 Kits (25 tests / kit)
Distribution: Worldwide Distribution -- US, Austria, Germany, Great Britain, Denmark, Norway, Sweden, Poland, Netherlands, Luxembourg, Belgium, Finland, France, Greece, Ireland, Italy, Portugal, Qatar, Saudi Arabia, Slovakia, Slovenia, and Switzerland.
Product codes and lots: Lot Expiration 028619, 6/8/2012; 028924, 7/5/2012; 029997, 10/7/2012; 030240, 11/6/2012; 030431, 11/24/2012; 030602, 12/8/2012; 030826, 12/24/2012; 030998, 1/11/2013; 031332, 2/4/2013; 031460, 2/19/2013; 031662, 3/6/2013; 031798, 3/20/2013; 031924, 3/30/2013; 032180, 4/28/2013; and 032106, 4/19/2013.

Product code JHI

K032563Class IIClinitest Hcg Pregnancy TestBayer Healthcare, LLC / cleared 2003-12-23

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)