Z-1715-2008

In vitro Diagnostic-Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin...

Name: Z-1715-2008 In vitro Diagnostic-Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin...
Creator: Siemens Medical Solutions Diagnostics
Published: 2008-04-04
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2008-04-04 / Terminated / root cause: design

FDA source

Siemens Medical Solutions Diagnostics began a recall of In vitro Diagnostic-Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760 The... on 2008-04-04. The reason FDA records is "False negative hCG results due to decreased sensitivity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1715-2008
Status: Terminated
Initiated: 2008-04-04
Posted: 2008-09-01
Terminated: 2012-03-15
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: In vitro Diagnostic-Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760 The Clinitest hCG Pregnancy Test is 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: False negative hCG results due to decreased sensitivity
Root cause tag: design
FDA root cause: Component design/selection
Action: Siemens notified Distributors ( Distributor Bulletin Urgent Field Safety Notice) and end-users (Customer Bulletin Urgent Field Safety Notice) Clinitest hCG Cassette Recall by letter dated 4/3/08. Users are requested to, discontinue use, discard the product, and immediately contact Siemens technical support representative or distributor for replacement cassettes from a different lot. If you have any question or have not received the recall notification, contact your local Siemens Distributor Relations Representative or Siemens Technical Support at 877-229-3711 option 13 then 5.
Quantity in commerce: 8180
Distribution: Nationwide
Product codes and lots: Lot 97552 Exp 05/16/08; Lot 97574 Exp 05/17/08

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