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Terminated

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

FDA Recall Z-0007-2010 · Posted 2009-10-06

Recalling FirmBiosite Inc
Recall StatusTerminated
Product CodeDKZ
Date Initiated2009-04-27
Date Terminated2012-04-02
Product Quantity113,575 cups distributed in total

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.

Firm 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]

Root Cause

Process control

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061718INNOVACON SPECTRUM II TEST CARDInnovacon, Inc. · 2006-11-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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