Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

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

• 2024-04-04Open, ClassifiedDevice Design

  ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35

  Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).

• 2024-04-04Open, ClassifiedDevice Design

  Alinity i Anti-HCV Reagent Kit, List Number 08P0521

  Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).

• 2014-09-19TerminatedPackaging process control

  VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. REF 680 2454, IVD -- Ortho-Clinical Diagnostics High Wycombe UK. Note that one sales unit has 5 Reagent Packs contained within it. Each Reagent Pack can test for 100 samples (patient, Quality Control, etc.).

  VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower than expected VITROS Anti-HCV test results due to an approximate signal loss of up to 66.2% which can result in unexpected negative test results being obtained for reactive sample fluids (quality control and patient samples).

• 2007-07-11TerminatedOther

  AxSYM Anti-HCV Reagent Pack; list 05C36; 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.

• 2006-11-04TerminatedOther

  Home Access-Hepatitis C Check; At Home Telemedicine Test Service for Hepatitis C ; each kit is composed of an outer box, a shrink-wrapped inner box that contains the blood collection card with an unique PIN, the instructions for use and ''Frequently Asked Questions'', a polybag component that includes two lancets, one gauze pad, one adhesive bandage and one alcohol prep pad, a specimen return envelope and a prepaid return mailer either designated as U.S. first class or FedEx; Home Access Health Corporation, Hoffman Estates, IL 60195-5200; UPC 0 83170 51000 5

  Wrong Expiration Date; The kits were labeled with Expiration/Use By dates; that exceed the expiration dates of the sterile safety lancet component of the kit.

• 2005-10-01TerminatedOther

  ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System.

  An error in the acceptance specification for the substrate blank optical density was discovered in the Bio-Tek ELx800 programming specifications for the ORTHO HCV Version 3.0 ELISA Test System Assay.

• TerminatedUnknown/Undetermined by firm

  OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.

  OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Antibody test Visual Reference Panel may be incorrect due to a complaint received from one of their customers. The customer reported they received the Ora Quick Ebola Visual Reference Panel instead of an OraQuick HCV Visual Reference Panel.