Home › Device types › MZO
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA product code MZO · Class 2 · Microbiology
32
Registered devices
1,668
Adverse events
7
Recalls
2
510(k) clearances
Devices with this code
Alinity — Abbott GmbHARCHITECT — Abbott GmbHARCHITECT — Abbott GmbHElecsys PreciControl Anti-HCV — Roche Diagnostics GmbHAlinity — Abbott GmbHAtellica™ IM aHCV — Siemens Healthcare Diagnostics Inc.VITROS — ORTHO CLINICAL DIAGNOSTICSVITROS — ORTHO CLINICAL DIAGNOSTICSElecsys Anti-HCV II — Roche Diagnostics GmbHARCHITECT — Abbott GmbHElecsys Anti-HCV Immunoassay — Roche Diagnostics GmbHHepatitis C Check — Home Access Health CorporationElecsys Anti-HCV II — Roche Diagnostics GmbHElecsys Anti-HCV II — Roche Diagnostics GmbHADVIA Centaur HCV — Siemens Healthcare Diagnostics Inc.Atellica™ IM aHCV QC — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® HCV — Siemens Healthcare Diagnostics Inc.Atellica IM aHCV 200T — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® Systems HCV QC — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott GmbHElecsys Anti-HCV II — Roche Diagnostics GmbHElecsys Anti-HCV II — Roche Diagnostics GmbHAtellica IM aHCV 200T — Siemens Healthcare Diagnostics Inc.Elecsys AntiHCV II immunoassay — Roche Diagnostics GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-04 | Abbott GmbH | Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential |
| 2024-03-04 | Abbott GmbH | Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential |
| 2016-01-15 | OraSure Technologies, Inc. | OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Antibody test Visual Reference Panel may be incorrect due to a com |
| 2014-08-06 | ORTHO-CLINICAL DIAGNOSTICS | VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower than expected VITROS Anti-HCV test results due to an approxima |
| 2007-04-23 | Abbott Laboratories | 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 placem |
| 2006-10-06 | Home Access Health Corp (HAHC) | 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. |
| 2004-03-09 | Diasorin Inc. | An error in the acceptance specification for the substrate blank optical density was discovered in the Bio-Tek ELx800 programming specifications for the ORTHO H |
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