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Elecsys Anti-HAV II

Roche Diagnostics GmbH · Model 08086630190 · UDI-DI 07613336129722

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510(k) clearances

982

Adverse events

Recalls

Facilities

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 the increase in the
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 placement of the reagent k
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 placement of the reagent k
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 for Hepatitus A virus

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.