Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Triage Drugs of Abuse Panel

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Triage Drugs of Abuse Panel see related information
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
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
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
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 = DKZ and Original Applicant = BIOSITE INCORPORATED
-
-