G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
Reported: April 17, 2013 Initiated: August 18, 2010 #Z-1075-2013
Product Description
G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
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.
Details
- Recalling Firm
- Tosoh Bioscience Inc
- Units Affected
- 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.
- Location
- Grove City, OH
Frequently Asked Questions
What product was recalled? ▼
G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.. Recalled by Tosoh Bioscience Inc. Units affected: 633.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 17, 2013. Severity: Low. Recall number: Z-1075-2013.
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