Recall database

Hemoglobin A1c Test System recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–2 of 2 recalls

Class IIOngoingZ-2703-2026

Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.

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 patient results.

Hemoglobin A1c Test System
Under Investigation by firm

Siemens Healthcare Dia…NYJul 15, 2026

Class IIOngoingZ-1657-2026

Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Enzymatic Hemoglobin A1c (A1c_E)

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 impacted by the recall.…

Hemoglobin A1c Test System
Process control

Siemens Healthcare Dia…NYApr 8, 2026