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Terminated

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.

FDA Recall Z-0987-2013 · Posted 2013-03-25

Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeLOM
Date Initiated2012-12-18
Date Terminated2013-07-31
Product Quantity12

Reason for Recall

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

Firm Action

The firm decided to correct the issue and and sent out Urgent Field Safety Notices to their customers dated 10/18/2012.

Root Cause

No Marketing Application

Distribution Pattern

Nationwide Distribution including AZ, CA, FL, GA, HI, LA, MA, MD, MO, NJ, NY, PA, RI, TN, TX, UT, and WA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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