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HEMOLYSIS WASHING SOLUTION 80H
ARKRAY USA, INC. · Model 103398 · UDI-DI 04987486015123
1
510(k) clearances
208
Adverse events
9
Recalls
32
Facilities
Description
These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. This product dilutes whole blood samples and is used to wash the sample tubes.
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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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.