Z-3244-2018Class II

G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement...

Name: Z-3244-2018 G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement...
Creator: Tosoh Bioscience Inc
Published: 2018-07-13
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2018-07-13 / Terminated / root cause: software

FDA source

Tosoh Bioscience Inc began a recall of G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This... on 2018-07-13. FDA classified it as Class II and gives the reason as "Analyzers were distributed with software which lacks a 510K". 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-3244-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-13
Posted: 2018-09-25
Terminated: 2020-07-08
Recalling firm: Tosoh Bioscience Inc
Product: G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
Product code: LCP Assay, Glycosylated Hemoglobin
Reason for recall: Analyzers were distributed with software which lacks a 510K
Root cause tag: software
FDA root cause: No Marketing Application
Action: On July 13, 2018, Tosoh Bioscience started to telephone customers to set up on-site visits. On July 16, 2018, Tosoh Bioscience began to issue URGENT MEDICAL DEVICE RECALL notices to customers via hand delivery. Immediate Actions to be taken by the Customer/User: - Thoroughly review the content of this letter with the Tosoh field service representative. - Allow the Tosoh field representative to verify the software version currently on your analyzer - If the software is v5.23, your analyzer needs no further action - If the software is v5.24, allow the Tosoh field representative to download all patient results from your analyzer, remove software version v5.24, and upload software version v5.23. - Continue to use your analyzer and report results with software v5.23 once these activities have been completed. - Complete and return the Acknowledgement Form to the Tosoh field representative. - File the Urgent Medical Device Recall notice with your laboratory records and forward the information to others in your laboratory. If you have obtained unexpected test results or received any complaints of illness or adverse events associated with the use of the analyzer, please contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764. Should you have any questions regarding this medical device recall, please feel free to contact Bernadette OConnell at (800) 248-6764 or by email at [email protected]. She will be available to answer any questions Monday - Friday, from 9:00 AM to 5:00 PM (PST).
Quantity in commerce: 8 units
Distribution: US Nationwide Distribution in states of - CA, OK, VA 7 WI
Product codes and lots: Serial Numbers: 14646304, 14917201, 14886112, 14616503, 14856212, 14887601, 14886212 & 14917201

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3244-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3244-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-25

Product code LCP

K131580Class IIAutomated Gylcohemoglobin Analyzer Hlc-723G8Tosoh Bioscience, Inc. / cleared 2014-01-23

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)