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Pointe Scientific, Inc. Rubella IgG

HORIBA INSTRUMENTS INCORPORATED · Model T8003-96 · UDI-DI 00811727015174

LFX Prescription
1
510(k) clearances
761
Adverse events
15
Recalls
35
Facilities

Description

Pointe Scientific, Inc. Rubella IgG is for the qualitative, semi-quantitative and quantitative detection of human IgG antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the assessment of the patient's immunological response to rubella, and as a qualitative screening test to determine the immune status of individuals, including women of childbearing age. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests

Recalls

DateFirmReason
2021-09-22bioMerieux, 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
2016-08-24Siemens 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
2016-08-24Siemens 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
2011-10-10Meridian Bioscience IncInternal 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
2010-12-22BioCheck IncProduct labels indicate that the products are for IVD use and they do not have an approved 510(k).
2010-07-19Bio-Rad LaboratoriesThe 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
2009-12-16Diasorin 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
2009-10-21Siemens 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
2009-10-21Siemens 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
2008-08-20Bio-Rad LaboratoriesElevated 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.