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Pointe Scientific, Inc. Rubella IgM

HORIBA INSTRUMENTS INCORPORATED · Model T8004-96 · UDI-DI 00811727015181

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510(k) clearances

761

Adverse events

Recalls

Facilities

Description

Pointe Scientific, Inc. Rubella IgM is for the qualitative detection of human IgM antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the diagnosis of rubella infection. A positive result is presumptive for the detection of anti-rubella IgM antibodies and presumptive for the diagnosis of acute or recent rubella infection. 96 tests

Recalls

Date	Firm	Reason
2021-09-22	bioMerieux, Inc.	bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed result
2016-08-24	Siemens Healthcare Diagnostics, Inc.	Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubell
2016-08-24	Siemens Healthcare Diagnostics, Inc.	Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubell
2011-10-10	Meridian Bioscience Inc	Internal testing has shown that the indicated kits produce false negative results when tested with some direct stool specimens. These false negative reactions are not observed for
2010-12-22	BioCheck Inc	Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
2010-07-19	Bio-Rad Laboratories	The EVOLIS Assay Protocol Files Software is configured in such a way that may result in a miscalculation of quantitative test results and/or an error in reporting positive/negative
2009-12-16	Diasorin Inc.	DiaSorin Rubella IgG kits of lot 123127A were packed with one coated microtiter plate instead of two microtiter plates as indicated in the product labeling. The risk is the possibi
2009-10-21	Siemens Healthcare Diagnostics Inc.	The recall was initiated because Siemens Healthcare Diagnostics has identified there is the potential for patient results to be biased low (-0.3 Sample to Cutoff [S/CO] ratio units
2009-10-21	Siemens Healthcare Diagnostics Inc.	The recall was initiated because Siemens Healthcare Diagnostics has identified there is the potential for patient results to be biased low (-0.3 Sample to Cutoff [S/CO] ratio units
2008-08-20	Bio-Rad Laboratories	Elevated optical density (OD) values with the kit Negative Control.

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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.