Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
G8 Automated HPLC Analyzer: HLC-723G8-ST Recalled by Tosoh Bioscience Inc Due to HbAE is known to interfere with the HbA1c...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Tosoh Bioscience Inc directly.
Affected Products
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 hemoglobin A1c (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
Quantity: 665
Why Was This Recalled?
HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Customers should exercise caution when reviewing chromatograms and ensure that Flag 43 is enabled on their device to avoid reporting invalid test results in the presence of HbAE.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Tosoh Bioscience Inc
Tosoh Bioscience Inc has 68 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report