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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Event Detail

Event ID 63946
Product Type Devices
Status Ongoing
Recalling Firm Abbott Laboratories, Inc
City Irving
State TX
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-18
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide Distribution including AZ, CA, FL, GA, HI, LA, MA, MD, MO, NJ, NY, PA, RI, TN, TX, UT, and WA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum. All shipped out to this date Class II Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assays (LNs 4P53 and 4P54) on the ARCHITECT i1000SR System were mistakenly made available on abbottdiagnostics.com in October 2012. Additionally, some i1000SR customers received notification through AbbottLink in November 2012 that assay files for LNs 4P53 and 4P54 were available. The ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assays (LNs 4P53 and 4P54) are not yet approved by the FDA for use on the ARCHITECT i1000SR, but they are under active review for approval. Abbott will notify you when FDA approval is obtained. This is a voluntary device recall. 12 Z-0987-2013
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