The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0674-2019·Announced 2019-01-02

Tosoh Bioscience Recalls ST AIA-PACK Testosterone Diagnostic Test Kits

Tosoh Bioscience is voluntarily recalling ST AIA-PACK Testosterone kits due to a Class II defect. The recall covers 26,745 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, which corresponds to a 'High' severity score (3) under the rubric, as it involves a risk of temporary or medically reversible adverse health consequences without reported fatalities or Class I classification.

Plain-English summary

Tosoh Bioscience Inc is voluntarily recalling ST AIA-PACK Testosterone (TES) kits. These in vitro diagnostic devices are used to measure testosterone levels in human serum on specific Tosoh AIA System analyzers. The recall involves 26,745 units of the product, covering all lots, which were distributed across the United States.

The recall was initiated on November 30, 2018, and is classified as Class II by the FDA. A Class II recall 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 nature of the defect or the reason for the recall.

The recall was terminated on January 14, 2021. The firm notified customers via letter. Consumers and healthcare facilities should check their inventory for these specific kits and follow the instructions provided by the manufacturer or the FDA regarding the return or disposal of the affected units.

The recalled product

Product
ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving…
Manufacturer
Tosoh Bioscience Inc
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
26,745

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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