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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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Event Detail

Event ID 66900
Product Type Devices
Status Ongoing
Recalling Firm Ortho-Clinical Diagnostics
City Rochester
State NY
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-25
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide distribution - all states.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs Product Code 1) 6801926, 2) 6801925, 3) 6802452 Lot numbers: 1) 6700, 2) 6731, 3) 6830 Expiry Dates: 1) 21 May 2013, 2) 24 July 2013, 3) 11 Sept 2013 Class II Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs due to false positive results. 1,920 kits Z-0557-2014
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