Hepatitis A Test (Antibody And Igm Antibody)

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2019-11-26TerminatedMaterial/Component Contamination

  ARCHITECT HAVAB-G Calibrator, REF 6L27-01

  Abbott has identified that Calibrator lot 08219BE00 is potentially impacted by an increase in Relative Light Units (RLUs) up to 94%. It has been confirmed that the increase in the calibrator RLU values may cause a decrease in the control values and patient results. Patient values generated using the impacted calibrator lot 08219BE00 may have changed interpretation from reactive to falsely non reactive. Results impacted may present as a (falsely) non reactive result that fall in the range between 0.50 to 0.99 S/CO.

• 2011-06-06TerminatedNonconforming Material/Component

  ARCHITECT HAVAB-M Assay Reagent; a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum; Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA, List 6L21-25

  The HAVAB-M reagent lot has reduced specificity and may cause an increase in false grayzone and/or false reactive results.

• 2010-05-19TerminatedPending

  ARCHITECT HAVAB-M Reagent A chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum.

  There is a potential to generate a false grayzone or reactive HAVAB-M result when the ARCHITECT AUSAB assay precedes the ARCHITECT HAVAB-M assay.

• 2008-05-06TerminatedNonconforming Material/Component

  ADVIA Centaur HAV IgM, 100 Test Kit, used on the ADVIA Centaur or XP, REF: 05004126, in vitro diagnostic Hepatitis A test, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591.

  Incorrect results: False reactive specimens on the ADVIA Centaur HAV IgM assay.

• 2007-07-11TerminatedOther

  AxSYM HAVAB-M 2.0 Reagent Pack; list 05E20; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

  Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument.

• 2007-07-11TerminatedOther

  AxSYM HAVAB 2.0 Reagent Pack; list 08D21; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

  Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument.

• 2005-04-27TerminatedOther

  DiaSorin ETI-HA-IGMK PLUS Enzyme Immunoassay for the Detection of IgM Antibody to Hepatitiis A Virus (IgM anti-HAV) in Human Serum or Plasma Catalog No. P001925. Manufactured by: DiaSorin S.p.A. Saluggia, Italy

  The package insert for Hepatitis A Virus IgM antibody kit (ETI-IgMK Plus, catalog P001925), may inadvertently contain pages 5 through 12 from the instructions for Hepatitus A virus Total antibody test (ETI-AB-HAVK Plus, catalog P001926).

• 2005-03-29TerminatedOther

  IMx HAVAB Controls In Vitro Test

  Abbott identified through investigational studies that IMxHAVAB Controls lot 21059Q100 is generating Negative Control values outside the upper range specified in the IMxHAVAB Package Insert.

• 2004-11-20TerminatedOther

  IMx HAVAB Controls are for In Vitro Diagnostic use. The kit is composed of 2 bottles of Negative and Positive controls of 9 mL each. These are prepared with recalcified human plasma and the preservative is Sodium Azide. The Negative Control is non-reactive for HbsAG, HIV-1, Anti-HCV, anti-HiV-1/HIV-2 and IgG antibody against HAV. The Positive Control is recalcified human plasma for anti-HAV diluted with Negative Control.

  Abbott identified through investigational studies that IMx HAVAB Controls lot 18220Q100 is generating Negative Control values outside the upper range specified in the IMx HAVAB Package Insert.

• TerminatedEmployee error

  Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma Catalog number: 07026773190

  Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous Border Area setting, (1.0 1.00) instead of (0.90 1.10).