Recall Z-0987-2013— Abbott Laboratories, Inc

Class II FDA medical device recall by Abbott Laboratories, Inc, initiated 2012-12-18, terminated 2013-07-31. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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.

Recalling firm

Abbott Laboratories, Inc

Classification

Class II

Status

Terminated

Initiated

2012-12-18

Terminated

2013-07-31

Firm location

Irving, TX, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.