Data Foundry

Medical device recalls 2018

G8 Automated HPLC Analyzer: HLC-723G8-ST — Class II medical device recall Z-2745-2018

Terminated recall by Tosoh Bioscience Inc, reported 2018-08-22, distributed nationwide. HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Customers shoul

Recall numberZ-2745-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmTosoh Bioscience Inc, Grove City, OH, United States
Recall initiated2018-06-06
Classified2018-08-10
Reported by FDA2018-08-22
Terminated2021-02-09
DistributedNationwide (US)
Countries outside the USBR, CL, CO, CR, DO, EC, PA, PE, UY
Quantity665
Reason classespotency, software

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 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2745-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.