Z-0009-2010

Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC...

Name: Z-0009-2010 Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC...
Creator: Biosite Inc
Published: 2009-04-27
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2009-04-27 / Terminated / root cause: manufacturing process

FDA source

Biosite Inc began a recall of Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG on 2009-04-27. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0009-2010
Status: Terminated
Initiated: 2009-04-27
Posted: 2009-10-06
Terminated: 2012-04-02
Recalling firm: Alere San Diego, Inc.
Product: Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Product code: DKZ Enzyme Immunoassay, Amphetamine
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.
Root cause tag: manufacturing process
FDA 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: [email protected]
Quantity in commerce: 113,575 cups distributed in total
Distribution: Nationwide Distribution
Product codes and lots: Lot Numbers: DOA8090784, DOA8090785, DOA8090786, DOA8090787 and DOA8110567.

Product code DKZ

K061718Class IIInnovacon Spectrum II Test CardInnovacon, Inc. / cleared 2006-11-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)