Tosoh Bioscience recalls all lots of AIA-PACK Folate (FOL) for in vitro diagnostic use only. This product is designed for quantitative folate measurement in human serum on Tosoh AIA System analyzers.
See the official notice for the full hazard description.
Tosoh Bioscience is recalling all lots of AIA-PACK Folate (FOL) products, which are designed for in vitro diagnostic use only. These products measure folate in human serum using Tosoh AIA System analyzers. The recall is for safety reasons related to their intended use.
The recall is for products designed for in vitro diagnostic use only. This means they are intended for laboratory testing, not for home use or other purposes. The hazard is related to their intended use, but the specific risk mechanism is not described in the recall notice.
Users of AIA-PACK Folate (FOL) for in vitro diagnostic testing are affected. Healthcare professionals who use these products for folate measurement in human serum are most at risk.
Check for AIA-PACK Folate (FOL) products labeled for in vitro diagnostic use only. These products are used with Tosoh AIA System analyzers to measure folate in human serum.
Look for the product name 'AIA-PACK Folate (FOL)' and the statement that it is designed for in vitro diagnostic use only.
The recall is for products designed for in vitro diagnostic use only. This means they are intended for laboratory testing, not for home use or other purposes.
The recall notice does not specify a remedy or action for affected products.
The product is designed for in vitro diagnostic use only, so it is safe for its intended purpose in laboratory settings.
We’ve drafted a message you can send Tosoh Biosc: AIA-PACK Folate (FOL) to request your refund or repair — edit it as you like.
Subject: Recall Z-0672-2019 — Tosoh Biosc: AIA-PACK Folate (FOL) Tosoh Biosc: AIA-PACK Folate (FOL) Hello, I own a Tosoh Biosc: AIA-PACK Folate (FOL) that is covered by recall Z-0672-2019 from Tosoh Biosc: AIA-PACK Folate (FOL). 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.
