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Recall Observatory FDA recall evidence

Device 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.

Z-2066-2015

February 10, 2015

Class III

Product summary

Firm
Tosoh Bioscience, Inc.
Event
Event 71493
Status
Terminated
Classification
Class III
Quantity
9 boxes/5 pouches
Official record key
device-enforcement:Z-2066-2015

Official wording

Reason: 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.

Code information: Catalog # 021446, Lot # H7-111W, Exp. Date 10-2015

Distribution pattern: Us Nationwide Distribution in the state ID including PR.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrectly labeled