Home › Device types › PDJ
Hemoglobin A1c Test System
FDA product code PDJ · Class 2 · Clinical Chemistry
46
Registered devices
208
Adverse events
9
Recalls
26
510(k) clearances
Devices with this code
TSKgel G8 Variant HSi — TOSOH CORPORATIONELUENT 80B — ARKRAY USA, INC.290 Sample Loader — TOSOH CORPORATIOND-100 — BIO-RAD LABORATORIES, INC.CAPI 3 Hb A1c — SEBIABioHermes Automated Glycohemoglobin Analyzer — Wuxi Biohermes Bio & Medical Technology Co.,Ltd.ADVIA Chemistry Enzymatic hemoglobin A1c Pretreatment — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott GmbHVARIANT II TURBO — BIO-RAD LABORATORIES, INC.AU — BECKMAN COULTER IRELAND INC.Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 — TOSOH CORPORATIONTSKgel GR01 HbA1c Column — TOSOH CORPORATIONHEMOLYSIS WASHING SOLUTION 80H — ARKRAY USA, INC.D-100 — BIO-RAD LABORATORIES, INC.Tina-quant Hemoglobin A1cDx Gen.3 — Roche Diagnostics GmbHAtellica CH A1c_E — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott GmbH90 Sample Loader — TOSOH CORPORATIONHbA1c Assay — SEKISUI DIAGNOSTICS, LLCDimension Vista System Flex reagent cartridge A1C KIT — Siemens Healthcare Diagnostics Inc.ADVIA Chemistry Enzymatic Hemoglobin A1c — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott GmbHTina-quant Hemoglobin A1cDx Gen.3 — Roche Diagnostics GmbHGR01 HbA1c Elution Buffer No. 3 — TOSOH CORPORATION
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 ca |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.