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U.S. Department of Health and Human Services

Class 3 Device Recall G7 Variant Elution Buffer HiS No. 1 (M)

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  Class 3 Device Recall G7 Variant Elution Buffer HiS No. 1 (M) see related information
Date Initiated by Firm February 10, 2015
Date Posted July 14, 2015
Recall Status1 Terminated 3 on October 01, 2015
Recall Number Z-2066-2015
Recall Event ID 71493
510(K)Number K011434  
Product Classification Assay, glycosylated hemoglobin - Product Code LCP
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.
Code Information Catalog # 021446, Lot # H7-111W, Exp. Date 10-2015
Recalling Firm/
Manufacturer		 Tosoh Bioscience, Inc.
6000 Shoreline Ct Ste 101
South San Francisco CA 94080-7606
For Additional Information Contact Mrs. Susan H Koss
650-615-4970 Ext. 5497
Manufacturer 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.
FDA Determined
Cause 2		 Error in labeling
Action 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.
Quantity in Commerce 9 boxes/5 pouches
Distribution Us Nationwide Distribution in the state ID including PR.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LCP and Original Applicant = TOSOH MEDICS, INC.
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