Siemens Healthcare recalls Dimension Ferritin (FERR) Flex reagent cartridges with lot EA922: Negative bias may cause inaccurate ferritin measurements, affecting iron metabolism disease diagnosis.
Negative Bias with Lot EA9227.
Siemens Healthcare is recalling Dimension Ferritin (FERR) Flex reagent cartridges with lot number EA9227 due to a negative bias that could lead to inaccurate ferritin measurements. This affects blood tests for iron-related conditions like hemochromatosis and iron deficiency anemia.
The reagent cartridge has a negative bias, meaning it may produce lower-than-actual ferritin measurements. This could lead to incorrect diagnoses of conditions like hemochromatosis and iron deficiency anemia if used in clinical testing.
Lab users who have the Dimension Ferritin (FERR) Flex reagent cartridge with lot number EA9227 are affected. Those testing for iron metabolism conditions are most at risk from inaccurate results.
Check the lot number on the cartridge, which should be EA9227 for this recall. The product is sold with catalog number RF440 and serial number 10444946.
Look for lot number EA9227 on the cartridge to confirm if it is recalled.
The negative bias means the cartridge may produce lower-than-actual ferritin measurements, potentially leading to inaccurate test results.
Inaccurate ferritin measurements could lead to incorrect diagnoses of iron metabolism conditions like hemochromatosis and iron deficiency anemia.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2229-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2229-2019 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.
