Tosoh HLC-723G8 Analyzer Recalled for HbA1c Test Inaccuracy
Tosoh Bioscience is recalling 682 HLC-723G8 analyzers because they may report inaccurate HbA1c values for patients with specific hemoglobin variants.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Tosoh Bioscience, Inc. is recalling 682 HLC-723G8 Analyzers used for HbA1c testing. The recall is due to a device defect that may result in HbA1c values with a negative bias in patients with hemoglobin variants C, D, E, and S.
The negative bias occurs at higher levels of HbA1c, such as 9%, but does not occur at the diagnostic medical decision point of 6.5%. The affected products were distributed worldwide, including to numerous U.S. states and countries in the Americas.
Consumers and healthcare facilities should contact Tosoh Bioscience for instructions on how to proceed with the recall. The source text does not specify a particular action for consumers beyond the recall notification.
The recalled product
- Product
- Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
- Manufacturer
- Tosoh Bioscience, Inc.
- Hazard
- Affected units
- 682
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 (1)
- All active analyzers
Distribution
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