Siemens Healthcare recalls specific A1c test reagents due to potential reagent carryover affecting patient samples and results. Affected units include certain lot numbers and material numbers.
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
Siemens Healthcare is recalling specific A1c test reagents that may cause inaccurate patient results due to reagent carryover. This could lead to incorrect diabetes management decisions if used without correction.
Reagent carryover can cause inaccurate test results for hemoglobin A1c levels. This may lead to incorrect diabetes management decisions if the test results are not corrected.
People using Siemens Atellica A1c test reagents with the specified lot numbers and material number 11097536 are affected. Those managing diabetes through regular blood tests are most at risk.
Check the Siemens Material Number 11097536 on the reagent packaging. Look for lot numbers listed: 110027, 110060, 110065, 110091, 110113, 110129, 110137, 110161, 110170, 110208, 110224, 110234, 110235, 110262, 110265, 110273, 110286, 110315, 110330, 110347, 110360.
Look for the Siemens Material Number 11097536 and the listed lot numbers on the reagent packaging.
The recall is due to potential reagent carryover that could impact patient test results and quality control.
Check the Siemens Material Number 11097536 and the specific lot numbers listed in the recall notice.
No action is required beyond checking the reagent packaging for the affected material number and lot numbers.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0929-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0929-2022 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.
