Z-2066-2015Class III

G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7

Name: Z-2066-2015 G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7
Creator: Tosoh Bioscience, Inc.
Published: 2015-02-10
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2015-02-10 / Terminated / root cause: labeling and UDI

FDA source

Tosoh Bioscience, Inc. began a recall of G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Elution Buffer HiS No 1... on 2015-02-10. FDA classified it as Class III and gives the reason as "The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of October 2015. The correct expiration date is October 2014". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2066-2015
Classification: Class III
Status: Terminated
Initiated: 2015-02-10
Posted: 2015-07-14
Terminated: 2015-10-01
Recalling firm: Tosoh Bioscience Inc
Product: G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Tosoh Automated Glycohemoglobin Analyzer HLC 723G7.
Product code: LCP Assay, Glycosylated Hemoglobin
Reason for recall: The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of October 2015. The correct expiration date is October 2014.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Tosoh Bioscience sent an Urgent Recall Notification letters dated February 10, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discard any remaining pouches of the product, complete and return the attached response form. For questions call Tosoh Technical Support at 1-800-248-6764.
Quantity in commerce: 9 boxes/5 pouches
Distribution: Us Nationwide Distribution in the state ID including PR.
Product codes and lots: Catalog # 021446, Lot # H7-111W, Exp. Date 10-2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2066-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2066-2015	Class III	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-14

Product code LCP

K011434Class IIG7 Automated Hplc AnalyzerTosoh Medics, Inc. / cleared 2001-09-18

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)