Agency classClass IIOur severity:High FDA (Devices)·Z-0673-2019·Announced 2019-01-02

Tosoh Bioscience Recalls ST AIA-PACK FT3 In Vitro Diagnostic Reagents

Tosoh Bioscience Inc is voluntarily recalling ST AIA-PACK FT3 reagents used for in vitro diagnostic testing of Free Triiodothyronine. The recall covers 24,083 units distributed nationwide.

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. Per the rubric, Class II recalls without explicit reports of hospitalization or serious injury are typically scored as High (3), representing a risk of temporary or medically reversible adverse health consequences.

Plain-English summary

Tosoh Bioscience Inc has voluntarily initiated a Class II recall of the ST AIA-PACK FT3 (Free Triiodothyronine) product. This in vitro diagnostic reagent is designed for the quantitative measurement of Free Triiodothyronine (FT3) in human serum or heparinized plasma on specific Tosoh AIA System analyzers. The recall affects 24,083 units and includes all lots of the product.

The recall was initiated on November 30, 2018, and the product was distributed nationwide in the United States. The FDA classified this recall as Class II, which indicates a situation that could cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The recall status is currently terminated, with a termination date of January 14, 2021.

Healthcare facilities and laboratories that use this product on Tosoh AIA System analyzers should stop using the affected units and contact Tosoh Bioscience Inc for further instructions. The source text does not specify the exact reason for the recall or report any specific illnesses or injuries associated with the product.

The recalled product

Product: ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine (FT3) in human serum or heparinized plasma on specific Tosoh AIA System analyzers.
Manufacturer: Tosoh Bioscience Inc
Category: Medical Device — In Vitro Diagnostic Reagents
Hazard: mis-labeling
quality-control
Affected units: 24,083

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 →

Same manufacturer · Tosoh Bioscience Inc

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Same hazard · mis labeling