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ASI Rubella IgM EIA Test
ARLINGTON SCIENTIFIC, INC. · Model NC-800096-AM · UDI-DI 00816057020522
1
510(k) clearances
761
Adverse events
15
Recalls
35
Facilities
Description
Detection of Rubella Virus Antibody
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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Get your free API keyRead the docsData 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.