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U.S. Department of Health and Human Services

Class 2 Device Recall G8 Analyzer

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  Class 2 Device Recall G8 Analyzer see related information
Date Initiated by Firm July 13, 2018
Create Date September 25, 2018
Recall Status1 Terminated 3 on July 08, 2020
Recall Number Z-3244-2018
Recall Event ID 80585
510(K)Number K131580  
Product Classification Assay, glycosylated hemoglobin - Product Code LCP
Product G8 Automated HPLC Analyzer - 723G8

Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
Code Information Serial Numbers: 14646304, 14917201, 14886112, 14616503, 14856212, 14887601, 14886212 & 14917201
Recalling Firm/
Manufacturer		 Tosoh Bioscience Inc
3600 Gantz Rd
Grove City OH 43123-1895
For Additional Information Contact
614-317-1909
Manufacturer Reason
for Recall		 Analyzers were distributed with software which lacks a 510K
FDA Determined
Cause 2		 No Marketing Application
Action On July 13, 2018, Tosoh Bioscience started to telephone customers to set up on-site visits. On July 16, 2018, Tosoh Bioscience began to issue URGENT MEDICAL DEVICE RECALL notices to customers via hand delivery. Immediate Actions to be taken by the Customer/User: - Thoroughly review the content of this letter with the Tosoh field service representative. - Allow the Tosoh field representative to verify the software version currently on your analyzer - If the software is v5.23, your analyzer needs no further action - If the software is v5.24, allow the Tosoh field representative to download all patient results from your analyzer, remove software version v5.24, and upload software version v5.23. - Continue to use your analyzer and report results with software v5.23 once these activities have been completed. - Complete and return the Acknowledgement Form to the Tosoh field representative. - File the Urgent Medical Device Recall notice with your laboratory records and forward the information to others in your laboratory. 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. Should you have any questions regarding this medical device recall, please feel free to contact Bernadette OConnell at (800) 248-6764 or by email at bernadette.oconnell@tosoh.com. She will be available to answer any questions Monday - Friday, from 9:00 AM to 5:00 PM (PST).
Quantity in Commerce 8 units
Distribution US Nationwide Distribution in states of - CA, OK, VA 7 WI
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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