Recall Z-0010-2010 ยท DKZ Enzyme Immunoassay, Amphetamine
Biosite Inc
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
| Date | Oct 6, 2009 (initiated Apr 27, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 113,575 cups distributed in total |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061718 | INNOVACON SPECTRUM II TEST CARD Innovacon, Inc., Nov 13, 2006 |