G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1075-2013.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1075-2013.
Recall terminated by FDA.
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Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
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- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1075-2013.
Tosoh Bioscience Inc
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Tosoh Bioscience Inc Recall FAQ
Tosoh Bioscience Inc is the subject of a medical devices safety report: G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.. The notice was published on August 18, 2010 by the U.S. Food and Drug Administration (FDA). Approximately 633 units are potentially affected.