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U.S. Department of Health and Human Services

Class 2 Device Recall Clnitest

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  Class 2 Device Recall Clnitest see related information
Date Initiated by Firm April 04, 2008
Date Posted September 01, 2008
Recall Status1 Terminated 3 on March 15, 2012
Recall Number Z-1715-2008
Recall Event ID 47384
510(K)Number K032563  
Product Classification hCG Cassette Pregnancy Test - Product Code JHI
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.
Code Information Lot 97552 Exp 05/16/08; Lot 97574 Exp 05/17/08
Recalling Firm/
Siemens Medical Solutions Diagnostics
2 Edgewater Dr
Norwood MA 02062-4637
For Additional Information Contact
Manufacturer Reason
for Recall
False negative hCG results due to decreased sensitivity
FDA Determined
Cause 2
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
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