Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS
FDA device recall Z-0007-2010 · posted 2009-10-06 · Terminated
Recall details
- Recalling firm
- Biosite Inc
- 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.
- 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
- Root cause
- Process control
- Status
- Terminated
- Product code
- DKZ
- Quantity affected
- 113,575 cups distributed in total
- Distribution
- Nationwide Distribution
- Date initiated
- 2009-04-27
- Date posted
- 2009-10-06
- Date terminated
- 2012-04-02
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INNOVACON SPECTRUM II TEST CARD (K061718) | Innovacon, Inc. | 2006-11-13 |