FDA Device Recall Z-0007-2010: Biosite Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0007-2010.

Recall Res Number

Z-0007-2010

Recalling Firm / Manufacturer

Biosite Inc

FEI Number

1000125596

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2009-04-27

Date Posted

2009-10-06

Date Terminated

2012-04-02

Product Code

DKZ

Event Number

52202

Product Quantity

113,575 cups distributed in total

Product Description 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

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 Details 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

Distribution Pattern Nationwide Distribution

Code Information / Serial Numbers Lot Numbers: DOA8080776, DOA8080777 and DOA8080778.

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Medical Device Recall: Z-0007-2010

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer