Tosoh HLC-723G8 Analyzer Recall Due to HbAE Interference
Tosoh Bioscience is recalling 665 HLC-723G8 Automated HPLC Analyzers because Hemoglobin AE (HbAE) interferes with HbA1c results on Version 5.23 software.
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 involves a medical device where a software defect can lead to invalid diagnostic results for a high-risk condition (diabetes), fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Tosoh Bioscience Inc is recalling 665 units of the G8 Automated HPLC Analyzer, specifically models HLC-723G8-ST and HLC-723G8-LA. These devices are intended for in vitro diagnostic use to measure hemoglobin A1c (HbA1c) in whole blood specimens to aid in the diagnosis of diabetes. The recall affects all active analyzers running Version 5.23 software.
The recall is being issued because Hemoglobin AE (HbAE) is known to interfere with the HbA1c assay on the current software version. This interference can lead to invalid test results if not properly managed. The affected units were distributed nationwide in the United States and in several foreign countries, including Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Panama, Peru, and Uruguay.
Customers using these devices should exercise caution when reviewing chromatograms. To avoid reporting invalid test results in the presence of HbAE, users must ensure that Flag 43 is enabled on their device.
The recalled product
- Product
- G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemog
- Manufacturer
- Tosoh Bioscience Inc
- Affected units
- 665
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 with Version 5.23 Software
Distribution
Distributed nationwide across the United States.
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