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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Product Detail

Product Description BD HLA-B27 Kit; 510(k) BK050073; Manufactured by BD Biosciences 2350 Qume Drive San Jose, CA 95131
Recall Number B-1367-13
Classification Class III
Code Info Model number 340183; Lot numbers 3029914 and 3035581
Product Distributed Qty 2
Reason For Recall Certain lots of HLA-B27 FITC/CD3 PE reagent contained in the HLA-B27 kit, contaminated with CD4 PE, were distributed.

Event Detail

Event Id 64632
Product Type Biologics
Status Ongoing
Recalling Firm BD Biosciences, Systems & Reagents
City San Jose
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-14
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern CA, GA, NC, NY, PA, OR, TX, OK, MO, VA, MI, NJ, CT, UT and to Australia, Canada, Belgium, China, India, South Korea, Taiwan.