Recall Z-0008-2010
Biosite Inc · initiated April 27, 2009
Product
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Codes / lots: Lot Numbers: DOA8090141, DOA8090142, DOA8090144, DOA8110132, DOA8110307, DOA8110573, DOA8110574 and DOA8110575.
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: Process control
Action taken
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
Details
- Recall number
- Z-0008-2010
- Initiated
- April 27, 2009
- Posted by FDA
- October 6, 2009
- Terminated
- April 2, 2012
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Quantity
- 113,575 cups distributed in total
- Distribution
- Nationwide Distribution
- Recalling firm
- Biosite Inc, San Diego, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0006-2010 | Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product…The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a… | 04/27/2009Terminated |
| Z-0007-2010 | Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A.…The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a… | 04/27/2009Terminated |
| Z-0009-2010 | Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product…The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a… | 04/27/2009Terminated |
| Z-0010-2010 | Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A.…The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a… | 04/27/2009Terminated |