Reported Apr 17, 2013 · Terminated
G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
Tosoh Bioscience Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tosoh Bioscience Inc · 3600 Gantz Road · Grove City, OH · 43123
Is this the product you have?
- G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
- Lot codes and dates
11103403111035031094281211514801116747061131370711273006109522121226630210872910R12506812112732061267820312728404120750071220521112627811126684031270870410361310R10792008R
- Amount recalled
- 633
Where it was sold
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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