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Beckman Coulter, Inc. · Model OSR6151 · UDI-DI 15099590010485
JZG
Prescription
1
510(k) clearances
53
Adverse events
6
Recalls
35
Facilities
Description
β-2 Microglobulin
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-21 | Siemens Healthcare Diagnostics, Inc. | Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH 2-Microglobulin (B2M) reag |
| 2021-12-01 | Siemens Healthcare Diagnostics, Inc. | 2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximat |
| 2018-03-09 | The Binding Site Group, Ltd. | The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use. |
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. |
| 2015-11-03 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has confirmed an increase in the rate of Abnormal Assay errors and calibration failures with the Dimension Vista B2MIC Flex reagent cartridge: Dimens |
| 2015-07-23 | Siemens Healthcare Diagnostics, Inc. | customers are receiving a high number of Abnormal Assay Errors or are not able to calibrate B2MIC when using Flex reagent cartridge B2MIC various lots. In failure mode, there is t |
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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.