Siemens Healthcare recalls Atellica CH Calcium_2 (CA_2) with material number 11097644 due to possible reagent carryover impacting test accuracy. Affected units include specific lot numbers and UDI.
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
Siemens Healthcare is recalling Atellica CH Calcium_2 (CA_2) reagents because they might cause inaccurate test results. This could affect patient samples and quality control. The recall is for specific lot numbers and UDI.
The reagents may have reagent carryover, which can lead to inaccurate test results. This might affect patient samples and quality control processes in laboratories. The issue is related to the reagent's chemical properties during testing.
Users of Atellica CH Calcium_2 reagents for laboratory testing are affected. Lab technicians and healthcare facilities using the recalled lot numbers are most at risk.
Check the Siemens Material Number 11097644 on the reagent label. Affected units include lot numbers 211392, 211438, 211484, 211522, and 211526, and UDI 00630414220697.
Look for the Siemens Material Number 11097644 and affected lot numbers on the reagent label.
The recall is for potential inaccurate test results, not direct patient injury. Siemens Healthcare states the hazard affects test accuracy, not immediate safety risks.
Check the Siemens Material Number 11097644 and lot numbers 211392, 211438, 211484, 211522, or 211526 on the label.
The recall does not specify a remedy, so contact Siemens Healthcare directly for guidance.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0928-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0928-2022 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
