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ELUENT 80B

ARKRAY USA, INC. · Model 103396 · UDI-DI 04987486015109

PDJ

510(k) clearances

208

Adverse events

Recalls

Facilities

Description

These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. These products are used to elute and remove hemoglobin in the column in order of binding strength.

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. Thi

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Data 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.