Siemens Healthcare recalls ADVIA Centaur Folate 100 test kits for potential elevated folate results due to homocysteine assay interference. All lots are affected. No action needed as the issue is not a safety hazard.
Homocysteine Assay May Cause Elevated Results in the Folate Assay
Siemens Healthcare is recalling all ADVIA Centaur Folate 100 test kits for possible elevated folate results caused by homocysteine assay interference. This does not pose a safety risk to users and requires no action.
The homocysteine assay in the test kit may cause the folate assay to show higher results than actual. This interference could lead to incorrect folate levels being reported, but it does not cause physical harm or safety risks.
Anyone using the Siemens ADVIA Centaur Folate 100 test kit for folate testing in serum or red blood cells. Laboratory users are most at risk due to potential inaccurate results.
The test kit is labeled as 'Siemens ADVIA Centaur Folate 100' for folate testing in serum or red blood cells. All lots are affected, so any kit with this product name is included in the recall.
Look for the product name 'Siemens ADVIA Centaur Folate 100' on the test kit label.
No, the recall is for potential inaccurate results, not a safety hazard.
No action is needed as the issue does not pose a safety risk.
All lots of Siemens ADVIA Centaur Folate 100 test kits for folate testing in serum or red blood cells.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0829-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0829-2020 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.
