Home › Device types › JZG
System, Test, Beta-2-Microglobulin Immunological
FDA product code JZG · Class 2 · Immunology
52
Registered devices
53
Adverse events
6
Recalls
53
510(k) clearances
Devices with this code
Dimension Vista® ß2-Microglobulin Flex® reagent cartridge — Siemens Healthcare Diagnostics Products GmbHAtellica CH B2M — Siemens Healthcare Diagnostics Inc.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.Beta-2 Microglobulin ELISA — DRG International IncAU — Beckman Coulter, Inc.B2Microglobulin (B2M) — RANDOX LABORATORIES LIMITEDBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.N Latex ß2-Microglobulin — Siemens Healthcare Diagnostics Products GmbHIMMULITE/IMMULITE 1000 Systems Beta-2-Microglobulin Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.IMMULITE/IMMULITE 1000 Systems Beta-2-Microglobulin Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDK-ASSAY® Beta-2 Microglobulin Serum / Plasma Calibrator — KAMIYA BIOMEDICAL COMPANY, LLCBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.Beckman Coulter Beta-2-Microglobulin Kit — AGILENT TECHNOLOGIES SINGAPORE PTE LTDBeta-2 Microglobulin ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungTinaquant ß2Microglobulin — Roche Diagnostics GmbHHuman Beta-2 Microglobulin Latex Kit for use on the Siemens BN™II — THE BINDING SITE GROUP LIMITEDβ2-Microglobin Kit (Latex-Enhanced Immunoturbidimetric Method) — Medicalsystem Biotechnology Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.AIA-PACK BMG Calibrator Set — TOSOH CORPORATIONK-ASSAY® Beta-2 Microglobulin Reagent — KAMIYA BIOMEDICAL COMPANY, LLCIMMULITE® 2000 Systems BMG Beta-2 Microglobulin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Recent 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-Micr |
| 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 concent |
| 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, dependin |
| 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 reage |
| 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 fail |
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