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
    • 11103403
    • 11103503
    • 10942812
    • 11514801
    • 11674706
    • 11313707
    • 11273006
    • 10952212
    • 12266302
    • 10872910R
    • 12506812
    • 11273206
    • 12678203
    • 12728404
    • 12075007
    • 12205211
    • 12627811
    • 12668403
    • 12708704
    • 10361310R
    • 10792008R
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 13, 2014 · Data as of Sep 19, 5:20 PM UTC

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