Tosoh G7 HPLC Analyzer Recalled for Beta-Thalassemia Detection Failure
Tosoh Bioscience Inc is recalling G7 HPLC analyzers because the Beta-thalassemia mode failed to detect the A2 peak in whole blood samples.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a functional failure to detect a specific peak, with no reported injuries or illnesses.
Plain-English summary
Tosoh Bioscience Inc is recalling 633 units of the G7 HPLC analyzer. This automated High Performance Liquid Chromatography (HPLC) system is used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood, specifically separating and reporting HbF and HbA2 quantitative percentages.
The recall was initiated after the firm received complaints that the A2 peak could not be detected when using the G7 Beta-thalassemia columns. This failure prevents the device from accurately reporting the quantitative percentages required for the presumptive identification of abnormal hemoglobins.
The affected units were distributed nationwide in the United States, including DC, Puerto Rico, and the Virgin Islands, as well as in Canada, Colombia, Chile, Brazil, and Jamaica. Users of these devices should contact Tosoh Bioscience Inc for further instructions regarding the recall.
The recalled product
- Product
- G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.
- Manufacturer
- Tosoh Bioscience Inc
- Hazard
- Affected units
- 633
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 11103403
- 11103503
- 10942812
- 11514801
- 11674706
- 11313707
- 11273006
- 10952212
- 12266302
- 10872910R
- 12506812
- 11273206
- 12678203
- 12728404
- 12075007
- 12205211
- 12627811
- 12668403
- 12708704
- 10361310R
Distribution
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