Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760
FDA Recall Z-1475-2008 · Posted 2008-09-01
Recalling FirmSiemens Medical Solutions Diagnostics
Recall StatusTerminated
Product CodeJHI
Date Initiated2007-10-17
Date Terminated2012-03-15
Product Quantity3065 kits
Reason for Recall
False positive hCG results
Firm 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.
Root Cause
Employee error
Distribution Pattern
Nationwide Canada, France, Korea, Netherlands, UK
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.