FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0010-2010
- Recalling firm
- Biosite Inc
- Product
- 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
- Status
- Terminated
- Initiated
- 2009-04-27
- Posted
- 2009-10-06
- Terminated
- 2012-04-02
- 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
- Lot, serial or model codes
- Lot Numbers: DOA8060786, DOA8060787 and DOA8090822.
- 510(k) numbers
- ["K061718"]
- PMA numbers
- not on file
- Product code
- DKZ
- Firm FEI
- 1000125596
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28