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U.S. Department of Health and Human Services

Class 3 Device Recall Tosoh Automated Glycohemoglobin Analyzer HLC723G7 Betathalassemia Analysis Mode

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  Class 3 Device Recall Tosoh Automated Glycohemoglobin Analyzer HLC723G7 Betathalassemia Analysis Mode see related information
Date Initiated by Firm August 18, 2010
Date Posted April 10, 2013
Recall Status1 Terminated 3 on May 13, 2014
Recall Number Z-1075-2013
Recall Event ID 56584
510(K)Number K020489  K011434  
Product Classification Hemoglobin a2 quantitation - Product Code JPD
Product G7 HPLC.

Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
Code Information 11103403, 11103503, 10942812, 11514801, 11674706, 11313707, 11273006, 10952212, 12266302, 10872910R, 12506812, 11273206, 12678203, 12728404, 12075007, 12205211, 12627811, 12668403, 12708704, 10361310R, 10792008R.
Recalling Firm/
Manufacturer		 Tosoh Bioscience Inc
3600 Gantz Road
Grove City OH 43123
For Additional Information Contact Susan (NMI) Koss
614-317-1909
Manufacturer Reason
for Recall		 The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports HbF and HbA2 quantitative percentages in whole blood. The firm received complaints that the A2 peak could not be detected with the G7 Beta-thalessemia columns.
FDA Determined
Cause 2		 Component change control
Action Please be aware that this is not a new recall. The firm has taken action. The firm stated that they have notified consignees via mail, with the list of notified customers maintained by the Regulatory Affairs/Quality Assurance department. The firm stated that they have notified distributors in the same way that they have notified other consignees, with a required confirmation to the firm of corrective actions.
Quantity in Commerce 633
Distribution Worldwide Distribution-USA (nationwide) including DC, Puerto Rico, Virgin Islands and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV, and the countries of Canada, Columbia, Chile, Brazil, and Jamaica.
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 = JPD and Original Applicant = TOSOH MEDICS, INC.
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