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U.S. Department of Health and Human Services

Class 2 Device Recall Clearview hCG Combo with Reference Line

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  Class 2 Device Recall Clearview hCG Combo with Reference Line see related information
Date Initiated by Firm September 28, 2006
Date Posted November 21, 2007
Recall Status1 Terminated 3 on August 03, 2012
Recall Number Z-0244-2008
Recall Event ID 44894
510(K)Number K992187  
Product Classification hCG Combo with Reference Line - Product Code JHI
Product Clearview hCG Combo with Reference Line, Wampole Laboratories, ABI List No/Product No. 6028KCV; 30 Individually pouched test cassettes with disposable pipettes, 1 Directional Insert; Inverness Medical Professional Diagnostics Group; Marketed by Wampole Laboratories, 2 Research Way, Princeton NJ 08540 USA
Code Information Model Number: 6028KCV, ABI Lot/Unit Code: 88982
Recalling Firm/
Manufacturer		 Applied Biotech Inc
10237 Flanders Ct
San Diego CA 92121-2901
For Additional Information Contact Martin Sellers
858-587-6771
Manufacturer Reason
for Recall		 Sensitivity: Kits contain test devices which may not meet the label claims for sensitivity, therefore use of such devices may produce false negative results with patient samples at or near the limit of detection of the product.
FDA Determined
Cause 2		 Process design
Action A Product Recall Notification dated 9/28/2006, was provided via fax, email or direct mail to all primary consignees. Customers were instructed to block all stock of affected lots in their warehouses, contact their primary consignees and advise them to discontinue use immediately and dispose of any unused materials; using a fax back form to communicate to the recalling firm the quantity blocked and disposed of so that arrangements could be made for providing replacement product
Quantity in Commerce 400 Kits (1,200 tests)
Distribution Worldwide: USA and Canada
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.
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