FDA Devices recall · Reported August 22, 2018
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.
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 …
Tosoh Bioscience Inc recalled G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usa… - a moderate-severity action.
G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usa… was recalled by Tosoh Bioscience Inc in August 22, 2018. Reason: HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Customers shou…. Check the official notice for the remedy. Verify recall #Z-2745-2018 with the FDA Devices before acting.
The recall
Tosoh Bioscience Inc issued this moderate-severity FDA Devices recall-HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Customers shou….
- Moderate
- severity level
- 665 units
- affected scope
- Class II
- classification
- August 22, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2745-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2745-2018 |
| Date reported | August 22, 2018 |
| Date initiated | June 6, 2018 |
| Recalling firm | Tosoh Bioscience Inc |
| Firm location | Grove City, OH |
| Affected scope | 665 |
| Distribution | Worldwide Distributed - US Nationwide. and the countries of Foreign distribution to Brazil, Caribbean, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Panama, Peru, and Uruguay. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2745-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
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Methodology · Corrections · Archive as of August 2026