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.
FDA Recall Z-0972-2012 · Posted 2012-02-07
Recalling FirmSiemens Healthcare Diagnostics
Recall StatusTerminated
Product CodeJHI
Date Initiated2011-12-15
Date Terminated2015-03-30
Product Quantity48,578 Kits (25 tests / kit)
Reason for Recall
A potential for false positive or increase in borderline results with patients and commercially available negative control material.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.