Home › Beckman Coulter, Inc. › Access Rubella IgG QC
Access Rubella IgG QC
Beckman Coulter, Inc. · Model 34439 · UDI-DI 15099590624873
LFX
Prescription
10
510(k) clearances
761
Adverse events
15
Recalls
35
Facilities
Description
The Access Rubella IgG QC is intended for monitoring the system performance of the Access Rubella IgG assay.
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.