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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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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
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.

Product Detail

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