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BioHermes Automated Glycohemoglobin Analyzer
Wuxi Biohermes Bio & Medical Technology Co.,Ltd. · Model BH60 · UDI-DI 06935784430016
10
510(k) clearances
220
Adverse events
9
Recalls
32
Facilities
Description
The BH60 Automated Glycohemoglobin Analyzer is intended for in vitro diagnostic use for the quantitative measurement of HbA1c in whole blood specimens in combination with Glycohemoglobin Analytical Column and Glycohemoglobin Reagent Kit produced by Wuxi Biohermes Bio & Medical Technology Co., Ltd. using ion-exchange high-performance liquid chromatography (HPLC).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-08 | Siemens Healthcare Diagnostics, Inc. | The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patien |
| 2026-02-23 | Siemens Healthcare Diagnostics, Inc. | A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not imp |
| 2023-04-17 | Ortho-Clinical Diagnostics, Inc. | Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis |
| 2022-06-09 | Abbott Laboratories | There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay. |
| 2022-06-09 | Abbott Laboratories | There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay. |
| 2022-06-09 | Abbott Laboratories | There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay. |
| 2022-02-09 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results. |
| 2020-03-23 | Abbott Diagnostics Technologies AS | The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-functional. |
| 2016-10-04 | Roche Diagnostics Operations, Inc. | .Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quant Hemoglobin A1c Gen.2 and Tina-quant Hemoglobin A1cDx Gen.2 cassettes/bottles. 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.