Siemens Healthcare Diagnostics recalled 21,291 Atellica CH A1c_E units distributed to laboratories nationwide and internationally in 2026. The recall addresses a depressed result bias when A1c_E is processed with RCRP on the same analyzer. Labs using separate analyzers are not impacted. Stop using the affected module immediately and follow manufacturer instructions. Contact Siemens or your lab’s F
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. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Siemens Healthcare Diagnostics, Inc. or your healthcare provider for instructions. Notification method: Letter
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Model numbers: SMN 11097536; UDI-DI: 00630414220505; Lot numbers: 150131, 150132, 150232, 150260, 150283, 150344, 150361, 150365, 150366, 150445, 150453, 150460, 150498, 150505, 150562, 150600, 150618, 150621. Sold domestically nationwide and internationally to laboratories. Sold from unknown start date. Price not disclosed.
The recall describes a potential depressed result for Atellica CH A1c_E when processing A1c_E and RCRP on the same analyzer. Negative bias and imprecision increase over time and are not consistent with the assay IFU. QC results may show a negative trend.
No injuries or incidents have been reported.
1. Stop using the product. 2. Review the recall instructions from Siemens and your facility’s quality team. 3. Contact Siemens Healthcare Diagnostics or your healthcare provider for remediation guidance. 4. Follow the provided recall instructions and monitor QC trends. 5. Document all actions and communications. 6. Refund or replacement information is provided by Siemens; contact details are below.
Phone: Unknown. Website: https://www.siemens-healthineers.com. Hours: Unknown.
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