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 |
Product Classification |
hCG Combo - Product Code JHI
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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/ Manufacturer |
Applied Biotech Inc 10237 Flanders Ct San Diego CA 92121-2901
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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 | 3,238 Kits (97,140 tests) |
Distribution | Worldwide: USA and Canada |
Total Product Life Cycle | TPLC Device Report |
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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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