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.
What this means for you
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
- 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.
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