Siemens Healthcare recalls Dimension Magnesium Flex reagent cartridges with specific lot numbers due to potential for inaccurate test results. The issue may cause unflagged patient results with a bias of -15 to -59%.
Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. The issue is not always detected by QC and erroneous results may be produced in the absence of an Abnormal Reaction flag. Based on customer data, imprecision leading to erroneous, unflagged patient results with a bias of -15 to -59% may occur
Siemens Healthcare is recalling Dimension Magnesium Flex reagent cartridges with certain lot numbers because they may produce inaccurate test results without triggering an 'Abnormal Reaction' flag. This could lead to incorrect patient outcomes if the cartridges are used.
The reagent cartridges may exhibit imprecision in quality control tests, leading to erroneous patient results without producing an 'Abnormal Reaction' flag. This can result in unflagged test results with a bias of -15 to -59%.
Users of the Dimension Magnesium Flex reagent cartridges with specific lot numbers are affected. Laboratory personnel and healthcare providers who use these cartridges for patient testing are most at risk.
Check the lot number on the cartridge label. Affected lots include FA2350, FA2356, GA2363, and FA3019 with specific Siemens Material Numbers.
Look for the lot number on the cartridge label to determine if it is affected.
The Dimension Magnesium Flex reagent cartridges may produce inaccurate test results without triggering an 'Abnormal Reaction' flag, leading to potential patient errors.
Affected lot numbers include FA2350, FA2356, GA2363, and FA3019 with specific Siemens Material Numbers.
Check the lot number on the cartridge label. Affected lots include FA2350, FA2356, GA2363, and FA3019 with specific Siemens Material 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-1816-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1816-2022 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.
