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U.S. Department of Health and Human Services

Class 2 Device Recall G8 Automated HPLC Analyzer

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  Class 2 Device Recall G8 Automated HPLC Analyzer see related information
Date Initiated by Firm June 06, 2018
Create Date August 11, 2018
Recall Status1 Terminated 3 on February 09, 2021
Recall Number Z-2745-2018
Recall Event ID 80257
510(K)Number K100304  
Product Classification Assay, glycosylated hemoglobin - Product Code LCP
Product G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674

Product Usage:
The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
Code Information All active analyzers with Version 5.23 Software
Recalling Firm/
Manufacturer		 Tosoh Bioscience Inc
3600 Gantz Rd
Grove City OH 43123-1895
For Additional Information Contact Ms. Bernadette O'Connell
800-248-6764
Manufacturer Reason
for Recall		 HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Customers should exercise caution when reviewing chromatograms and ensure that Flag 43 is enabled on their device to avoid reporting invalid test results in the presence of HbAE.
FDA Determined
Cause 2		 Software design
Action The firm issued an Urgent Medical Device Recall letter to its affected customers on June 6, 2018. In the notice, Tosoh is currently investigating a resolution to this issue to eliminate interference from hemoglobin variants. In the interim, customers should carefully review the chromatography to determine whether or not a variant peak is detected and follow the recommendations included in the letter. Customers were asked to complete and return the attached Acknowledgement Form and the flag setting confirmation to Tosoh Bioscience, Inc., within 14-days of receiving this notification by FAX, email, or postal mail as indicated on the form. If you have obtained unexpected test results or received any complaints of illness or adverse events associated with the use of the analyzer, please contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764.
Quantity in Commerce 665
Distribution Worldwide Distributed - US Nationwide. and the countries of Foreign distribution to Brazil, Caribbean, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Panama, Peru, and Uruguay.
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 BioScience, Inc.
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