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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens CLINITEST hCG

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  Class 2 Device Recall Siemens CLINITEST hCG see related information
Date Initiated by Firm December 15, 2011
Date Posted February 07, 2012
Recall Status1 Terminated 3 on March 30, 2015
Recall Number Z-0972-2012
Recall Event ID 60662
510(K)Number K032563  
Product Classification Radioimmunoassay, human chorionic gonadotropin - Product Code JHI
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.
Code Information 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.  
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact SAME
914-524-2955
Manufacturer Reason
for Recall		 A potential for false positive or increase in borderline results with patients and commercially available negative control material.
FDA Determined
Cause 2		 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.
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.
510(K) Database 510(K)s with Product Code = JHI and Original Applicant = BAYER HEALTHCARE, LLC
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