The Recall Desk
Agency classClass IIIOur severity:LowFDA (Devices)·Z-2066-2015·Announced 2015-07-22

Tosoh Glycohemoglobin Analyzer Buffer Recalled for Incorrect Expiration Date Labeling

Tosoh Bioscience is recalling G7 Variant Elution Buffer HiS no. 1 (M) because it is labeled with an expiration date of October 2015 instead of the correct October 2014.

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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling error regarding the expiration date.

Plain-English summary

Tosoh Bioscience, Inc. is recalling the G7 Variant Elution Buffer HiS no. 1 (M), a component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. The recall involves 9 boxes containing 5 pouches each, identified by Catalog # 021446, Lot # H7-111W, and an expiration date of 10-2015.

The product is being recalled because it is incorrectly labeled with an expiration date of October 2015. The correct expiration date for this lot is October 2014. The affected product was distributed nationwide in the United States, including Puerto Rico.

The U.S. Food and Drug Administration has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Users of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7 should check their inventory for this specific lot and expiration date.

The recalled product

Product
G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Tosoh Automated Glycohemoglobin Analyzer HLC 723G7.
Manufacturer
Tosoh Bioscience, Inc.
Category
Medical Device — Laboratory Reagent
Hazard

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 (3)

  • Catalog # 021446
  • Lot # H7-111W
  • Exp. Date 10-2015

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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