The Recall Desk
Agency classClass IIIOur severity:LowFDA (Devices)·Z-2282-2016·Announced 2016-08-03

Tosoh Bioscience Recalls Progesterone 3 Calibrator Sets Due to Incorrect IFU Lot Number

Tosoh Bioscience is recalling 41 sets of Progesterone 3 Calibrators because the included Instructions for Use (IFU) listed the incorrect lot number.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation error (incorrect lot number on the IFU) rather than a product defect.

Plain-English summary

Tosoh Bioscience, Inc. is recalling 41 single sets of the Progesterone 3 Calibrator Set. The recall is limited to the Instructions for Use (IFU) included in the package, which contained the incorrect lot number. The calibrators themselves do not require correction.

The affected product is identified by Catalog Number 02534001 and Lot G13C303. These units were distributed nationwide in the United States, specifically in the states of Alabama, California, Colorado, Florida, Kentucky, Massachusetts, New York, Ohio, South Carolina, Texas, Utah, Virginia, and Wisconsin.

This is a Class III recall, indicating that the use of or exposure to the product is not likely to cause adverse health consequences. Users should stop using the affected IFU and contact Tosoh Bioscience for a replacement or further instructions.

The recalled product

Product
Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.
Manufacturer
Tosoh Bioscience, Inc.
Category
Medical Device — Laboratory Reagents
Hazard

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

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