Home › Device types › LOL
Hepatitis A Test (Antibody And Igm Antibody)
FDA product code LOL · Class 2 · Microbiology
38
Registered devices
982
Adverse events
12
Recalls
26
510(k) clearances
Devices with this code
MONOLISA — BIO-RADAtellica IM aHAVT — Siemens Healthcare Diagnostics Inc.VITROS — ORTHO CLINICAL DIAGNOSTICSADVIA Centaur® HAV IgM — Siemens Healthcare Diagnostics Inc.Atellica IM aHAVM — Siemens Healthcare Diagnostics Inc.Atellica IM aHAVT QC — Siemens Healthcare Diagnostics Inc.Alinity — Abbott GmbHLIAISON® Control anti-HAV — DIASORIN SPAVITROS — ORTHO CLINICAL DIAGNOSTICSARCHITECT — Abbott GmbHARCHITECT — Abbott GmbHElecsys Anti-HAV II — Roche Diagnostics GmbHAlinity — Abbott GmbHADVIA Centaur® aHAVT QC — Siemens Healthcare Diagnostics Inc.Alinity — Abbott GmbHElecsys AntiHAV Assay — Roche Diagnostics GmbHMONOLISA — BIO-RADADVIA Centaur® aHAVT — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® Systems QC aHAVT — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® aHAVT — Siemens Healthcare Diagnostics Inc.Alinity — Abbott GmbHLIAISON® anti-HAV — DIASORIN SPAAtellica IM aHAVM QC — Siemens Healthcare Diagnostics Inc.Elecsys Anti-HAV II — Roche Diagnostics GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-03-09 | Abbott Gmbh & Co. KG | An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots. |
| 2019-11-07 | Abbott Gmbh & Co. KG | 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 |
| 2019-10-28 | Roche Diagnostics Operations, Inc. | 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). |
| 2018-12-17 | Roche Diagnostics Corporation | Potential for erroneous result messages for the Anti-HAV IgM assay when run on the cobas e 602 module. Discrepant result reporting may result. |
| 2011-04-20 | Abbott Laboratories | The HAVAB-M reagent lot has reduced specificity and may cause an increase in false grayzone and/or false reactive results. |
| 2009-12-30 | Abbott Diagnostics International, Ltd. | 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. |
| 2008-01-12 | Siemens Medical Solutions Diagnostics | Incorrect results: False reactive specimens on the ADVIA Centaur HAV IgM assay. |
| 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 |
| 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 |
| 2005-04-08 | Diasorin Inc. | 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 f |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.