Date Initiated by Firm | November 06, 2008 |
Date Posted | March 17, 2009 |
Recall Status1 |
Terminated 3 on October 13, 2011 |
Recall Number | Z-1088-2009 |
Recall Event ID |
50689 |
510(K)Number | K973784 |
Product Classification |
Amphetamine Enzyme Immunoassay - Product Code DKZ
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Product | Triage Drugs of Abuse Panel, Model Number: 95000.
Is an immunoassay test kit used for the qualitative determination of the presence of the major metabolites of drugs of abuse in urine. |
Code Information |
Lot/Unit Codes: 186625 |
Recalling Firm/ Manufacturer |
Biosite Inc 9975 Summers Ridge Rd San Diego CA 92121
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For Additional Information Contact | 858-455-4808 Ext. 3015 |
Manufacturer Reason for Recall | The recall was initiated after the firm's investigations confirmed that, while lot #186625 passed all internal specifications and quality requirements, the incidence of false positive PCP results has exceeded their post market surveillance thresholds for customer complaints in the field. In addition, the firm has been able to reproduce false positive results reported by customers and as a result |
FDA Determined Cause 2 | Other |
Action | Consignee notification was initiated on 11/6/2008 with Urgent Medical Device Recall notifications, dated 11/5/2008 and mailed to domestic customers sent via US Postal Service Priority Mail and to foreign customers via FedEx. The notice informed customers of the reason for the recall and requested the customers immediately discontinue all use of lot #186625 and discard all affected product in accordance with your local regulations. The customers were also instructed to complete and fax an attached Customer/Distributor Verification form within 10 days. |
Quantity in Commerce | 2634 kits |
Distribution | Worldwide Distribution -- USA and country of 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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510(K) Database | 510(K)s with Product Code = DKZ
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