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U.S. Department of Health and Human Services

Class 2 Device Recall MultiDrug iCup Drug Screen Test Cup

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  Class 2 Device Recall MultiDrug iCup Drug Screen Test Cup see related information
Date Initiated by Firm April 27, 2009
Date Posted October 06, 2009
Recall Status1 Terminated 3 on April 02, 2012
Recall Number Z-0006-2010
Recall Event ID 52202
510(K)Number K061718  K061718  
Product Classification Enzyme immunoassay, amphetamine - Product Code DKZ
Product Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A.

Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Code Information Lot Numbers: DOA8080780, DOA8080781, DOA8080782, DOA8080783 and DOA8080784.
Recalling Firm/
Manufacturer		 Biosite Inc
9975 Summers Ridge Rd
San Diego CA 92121
For Additional Information Contact
877-441-7440
Manufacturer Reason
for Recall		 The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a result, there is a potential for affected lots of cups to leak urine after an extended period of time.
FDA Determined
Cause 2		 Process control
Action Biosite, Inc. issued a "Notice of Correction" letter dated May 1, 2009 to consignees describing the problem and instructed users of proper use in order to avoid any cross contamination of samples until all affected product is completely used. For further information, contact Biosite, Inc. using the following information: Biosite Incorporated, an Inverness Medical Company 9975 Summers Ridge Road San Diego, CA 92121 Phone: 1-877-441-7440, option 2 Fax: 1-858-695-7100 Email: productadvisory@invmed.com
Quantity in Commerce 113,575 cups distributed in total
Distribution Nationwide Distribution
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 = INNOVACON, INC.
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