Siemens recalls Magnesium Flex reagent cartridges (Material #10445158) that may cause QC failures or incorrect patient results. Affected lots include 21253BB, 21263BA, and 21335AA. Contact Siemens for remedy.
Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay flags. When this issue occurs, there is a potential for QC failures or erroneous patient results which may lead to repeat and follow-up testing.
Siemens is recalling Magnesium Flex reagent cartridges that may cause inaccurate test results or repeat testing. This could lead to incorrect diagnoses or treatments if the cartridges are used without proper quality control.
The cartridges may show imprecision and intermittent abnormal assay flags, leading to potential QC failures. This could cause incorrect patient results, requiring repeat testing and possibly affecting diagnosis or treatment decisions.
Users of the Siemens Dimension Vista system who have the affected reagent cartridges (lots 21253BB, 21263BA, 21335AA) are most at risk. Healthcare facilities using these cartridges for magnesium testing may need to verify results.
Check the lot number on the cartridge: 21253BB, 21263BA, or 21335AA. The product uses Material #10445158 and Catalog #K3057 in the Dimension Vista system.
Look for lot numbers 21253BB, 21263BA, or 21335AA on the reagent cartridge.
The cartridges may cause QC failures or erroneous patient results, leading to repeat testing and potential misdiagnosis.
Check the lot number: 21253BB, 21263BA, or 21335AA. The product uses Material #10445158 and Catalog #K3057.
The recall does not specify a remedy, so contact Siemens Healthcare Diagnostics for further instructions.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-0830-2022 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-0830-2022 from Siemens. 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.
