Siemens Healthcare recalls Atellica B2M assay lot 211446 due to potential inaccurate results. This may lead to misdiagnosis of kidney disease. Affected units have specific Siemens material numbers and lot numbers.
¿2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias on patient samples of up to -10.5% at a B2M concentration of approximately 15 mg/L
Siemens Healthcare is recalling a specific lot of their B2M assay kits because they can produce inaccurate test results. This could lead to incorrect diagnoses of kidney disease. Affected kits have a specific lot number and Siemens material number.
The assay kit can show results that are too high by up to 20.9% or too low by up to 10.5% compared to actual B2M levels in patient samples. This inaccuracy could lead to incorrect kidney disease diagnoses.
Healthcare providers using the Atellica B2M assay kit with lot number 211446 for kidney disease testing are affected. Patients receiving results from this specific kit may be at risk of misdiagnosis.
Check for Siemens Material Number 11097635 and Lot Number 211446 on the kit. The kit is used for in vitro diagnostic testing of B2M levels in human serum and plasma.
Look for Siemens Material Number 11097635 and Lot Number 211446 on the assay kit.
The assay can produce inaccurate results, showing up to 20.9% higher or 10.5% lower B2M levels than actual values, which could lead to misdiagnosis of kidney disease.
Check the kit for Siemens Material Number 11097635 and Lot Number 211446. If you have this specific lot, contact Siemens Healthcare for guidance.
The recall record does not mention any remedy or corrective action for this specific lot.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0440-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0440-2022 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.
