Biosite Inc Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Brand
Biosite Inc
Lot Codes / Batch Numbers
Lot Numbers: DOA8080776, DOA8080777 and DOA8080778.
Products Sold
Lot Numbers: DOA8080776, DOA8080777 and DOA8080778.
Biosite Inc is recalling Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent P due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026