RecallDepth

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.

This recall has been terminated (originally issued July 14, 2015).

Company
Tosoh Bioscience, Inc.
Recall Initiated
February 10, 2015
Posted
July 14, 2015
Terminated
October 1, 2015
Recall Number
Z-2066-2015
Quantity
9 boxes/5 pouches
Firm Location
South San Francisco, CA
Official Source
View on FDA website ↗

Reason for Recall

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.

Distribution

Us Nationwide Distribution in the state ID including PR.

Lot / Code Info

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

Root Cause

Error in labeling

Action Taken

Tosoh Bioscience sent an Urgent Recall Notification letters dated February 10, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discard any remaining pouches of the product, complete and return the attached response form. For questions call Tosoh Technical Support at 1-800-248-6764.

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