The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0672-2019·Announced 2019-01-02

Tosoh Bioscience Recalls AIA-PACK Folate In Vitro Diagnostic Reagents

Tosoh Bioscience Inc is voluntarily recalling AIA-PACK Folate reagents used for in vitro diagnostic testing due to a Class II safety concern.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which indicates a risk of temporary or medically reversible adverse health consequences. Per the rubric, this corresponds to a High severity score, especially as no specific injuries or illnesses are reported in the source text.

Plain-English summary

Tosoh Bioscience Inc is voluntarily recalling AIA-PACK Folate (FOL) reagents. These products are designed for in vitro diagnostic use only to measure folate levels in human serum on Tosoh AIA System analyzers. The recall covers 19,366 units distributed nationwide in the United States.

The U.S. Food and Drug Administration classified this recall as Class II. This classification indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The source text does not specify the exact reason for the recall or report any specific illnesses or injuries.

The recall was initiated by the firm on November 30, 2018, and was terminated on January 14, 2021. Affected users were notified via letter. Because the specific hazard is not detailed in the provided source text, users should refer to the official FDA recall notice for specific instructions on handling the product.

The recalled product

Product
AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.
Manufacturer
Tosoh Bioscience Inc
Category
Medical Device — In Vitro Diagnostic Reagents
Hazard
Affected units
19,366

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • all lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Tosoh Bioscience Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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