Class 2 Device Recall Clinitest

• Date Initiated by Firm: October 17, 2007
• Date Posted: September 01, 2008
• Recall Status: Terminated on March 15, 2012
• Recall Number: Z-1475-2008
• Recall Event ID: 47352
• Product Classification: Visual, Pregnancy Hcg, Prescription Use - Product Code JHI
• Product: Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system; Product Number: 1760
• Code Information: Lot Number: 97266 Exp. March 12, 2008
• Recalling Firm/ Manufacturer: Siemens Medical Solutions Diagnostics; 2 Edgewater Dr; Norwood MA 02062-4637
• For Additional Information Contact: SAME; 508-359-3877
• Manufacturer Reason for Recall: False positive hCG results
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.