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Hemoglobin A1c Test System
FDA product code PDJ · Class 2 · Clinical Chemistry
48
Registered devices
220
Adverse events
9
Recalls
27
510(k) clearances
Devices with this code
CAPI 3 Hb A1c — SEBIAARCHITECT — Abbott GmbHTina-quant Hemoglobin A1cDx Gen.3 — Roche Diagnostics GmbHELUENT 80A — ARKRAY USA, INC.D-100 — BIO-RAD LABORATORIES, INC.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.AU — BECKMAN COULTER IRELAND INC.ARCHITECT — Abbott GmbHD-100 — BIO-RAD LABORATORIES, INC.GR01 HbA1c Elution Buffer No. 2 — TOSOH CORPORATIONTosoh Automated Glycohemoglobin Analyzer HLC-723GR01 LA — TOSOH CORPORATIONDimension Vista System Flex reagent cartridge A1C KIT — Siemens Healthcare Diagnostics Inc.Tina-quant Hemoglobin A1cDx Gen.3 — Roche Diagnostics GmbHELUENT 80B — ARKRAY USA, INC.D-10 — BIO-RAD LABORATORIES, INC.ADVIA Chemistry Enzymatic Hemoglobin A1c — Siemens Healthcare Diagnostics Inc.DILUENT 80 — ARKRAY USA, INC.ARCHITECT — Abbott GmbHD-100 — BIO-RAD LABORATORIES, INC.D-10 — BIO-RAD LABORATORIES, INC.Dimension Clinical Chemistry System A1C Kit — Siemens Healthcare Diagnostics Inc.TSKgel G8 Variant HSi — TOSOH CORPORATIONELUENT 80CV — ARKRAY USA, INC.BioHermes Automated Glycohemoglobin Analyzer — Wuxi Biohermes Bio & Medical Technology Co.,Ltd.
Recent 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 e |
| 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 a |
| 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- |
| 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 c |
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