Medical device recalls

Tosoh Bioscience, Inc. recalls G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Us…

Recall date
February 10, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2066-2015
FDA classification
Class III
Brand / firm
Tosoh Bioscience, Inc.
Sold / distributed
Us Nationwide Distribution in the state ID including PR.

Why it was recalled

The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of October 2015. The correct expiration date is October 2014.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.

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