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Abbott Laboratories, Inc recalls ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54
Recalled April 3, 2013 · FDA recall Z-0987-2013 · Abbott Laboratories
Hazard
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 AR · FDA Class II
Units
12
Sold at
Nationwide Distribution including AZ, CA, FL, GA, HI, LA, MA, MD, MO, NJ, NY, PA, RI, TN, TX, UT, and WA.
Description
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 AR
Product
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.
Manufacturer(s)
Abbott Laboratories, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →