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U.S. Department of Health and Human Services

Class 2 Device Recall Clearview hCG Combo

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  Class 2 Device Recall Clearview hCG Combo 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-0245-2008
Recall Event ID 44894
510(K)Number K992187  
Product Classification hCG Combo - Product Code JHI
Product Clearview hCG Combo Waived for urine & Moderate for serum, Wampole Laboratories, ABI List No/Product No. 6026KCV; Contents 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 6026KCV; ABI Lot Code: 87494
Recalling Firm/
Applied Biotech Inc
10237 Flanders Ct
San Diego CA 92121-2901
For Additional Information Contact Martin Sellers
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 3,238 Kits (97,140 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.