Z-1225-2017Class II

Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing

Name: Z-1225-2017 Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing
Creator: Tosoh Bioscience, Inc.
Published: 2016-11-07
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2016-11-07 / Terminated / root cause: software

FDA source

Tosoh Bioscience, Inc. began a recall of Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing on 2016-11-07. FDA classified it as Class II and gives the reason as "The device defect associated with this recall may result in HbA1c values with a negative bias in patients with the hemoglobin variants C, D, E and S. The negative bias occurs at the higher levels of HbA1c, e.g. 9%, but...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1225-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-07
Posted: 2017-02-17
Terminated: 2021-02-09
Recalling firm: Tosoh Bioscience Inc
Product: Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
Product code: JCM Control, Hemoglobin, Abnormal
Reason for recall: The device defect associated with this recall may result in HbA1c values with a negative bias in patients with the hemoglobin variants C, D, E and S. The negative bias occurs at the higher levels of HbA1c, e.g. 9%, but not at the diagnostic medical decision point of 6.5%.
Root cause tag: software
FDA root cause: Software design
Action: Recall notification letters were distributed to customers on 11/7/16. The letters instructed customers to review the chormatography to determine whether or not a variant peak was detected. If so, restest the sample using an alternative method.
Quantity in commerce: 682 analyzers
Distribution: Worldwide distribution. The products were shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, AND WY. The recalled products were shipped to the following countries: Brazil, Chile, Columbia, Guatemala, Costa Rica, Dominican Republic, Eduador, Nicaragua, Panama, Peru, Puerto Rico, Uruguay,
Product codes and lots: All active analyzers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1225-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1225-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-01	2017-02-17

Product code JCM

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)