Tosoh Bioscience recalls all lots of AIA-PACK B12 (Vitamin B12) for in vitro diagnostic use due to potential fluorescein interference causing inaccurate vitamin B12 test results.
Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays
Tosoh Bioscience is recalling all lots of AIA-PACK B12 (Vitamin B12) for in vitro diagnostic use because it may cause inaccurate test results due to fluorescein interference. This affects laboratory tests that measure vitamin B12 levels in blood. The recall is for safety and accuracy in medical testing.
The AIA-PACK B12 may interact with fluorescein in samples, causing the test to show higher vitamin B12 levels than actually present. This interference can lead to inaccurate test results, potentially affecting clinical decisions.
Laboratories using Tosoh AIA-PACK B12 for vitamin B12 testing are affected. Users most at risk are those conducting tests where fluorescein interference could lead to inaccurate results.
The product is labeled as AIA-PACK B12 (Vitamin B12) for in vitro diagnostic use. All lots are affected, so no specific model or date is needed to identify the recalled item.
Look for the product name 'AIA-PACK B12 (Vitamin B12)' on the label for in vitro diagnostic use.
The recall is for potential inaccuracies in test results, not safety risks. The product is designed for in vitro diagnostic use only.
No action is required for the product itself, but labs should verify test results if they used this product.
The recall does not specify a remedy, so labs should check with their supplier for guidance on handling the product.
We’ve drafted a message you can send Tosoh Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-0671-2019 — Tosoh Bioscience Tosoh Bioscience Hello, I own a Tosoh Bioscience that is covered by recall Z-0671-2019 from Tosoh Bioscience. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
