Z-0601-2019Class III

Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of...

Name: Z-0601-2019 Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of...
Creator: Tosoh Bioscience Inc
Published: 2018-10-05
License: https://open.fda.gov/license/

Tosoh Bioscience Inc / initiated 2018-10-05 / Terminated / root cause: design

FDA source

Tosoh Bioscience Inc began a recall of Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation on 2018-10-05. FDA classified it as Class III and gives the reason as "Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days product stability claim. If degradation of these controls occurs, P00 peaks may be seen and the % HbA1c control...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0601-2019
Classification: Class III
Status: Terminated
Initiated: 2018-10-05
Posted: 2018-12-13
Terminated: 2020-06-16
Recalling firm: Tosoh Bioscience Inc
Product: Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.
Product code: LCP Assay, Glycosylated Hemoglobin
Reason for recall: Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days product stability claim. If degradation of these controls occurs, P00 peaks may be seen and the % HbA1c control values may drift higher than the assigned range. This may result in delays when performing routine instrument quality control. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh has received two (2) complaints related to this issue with no serious injuries reported.
Root cause tag: design
FDA root cause: Device Design
Action: The firm sent notification to consignees on October 5, 2018, via Urgent Medical Device Recall letter. The letter informed consignees of the potential degradation of HbA1c control lot 7055 prior to the 60-days product stability claim. Immediate Actions to be taken by the Customer " Review the content of this letter with your laboratory staff. " Inform laboratory staff to avoid storing the control material in direct exposure to light. " Complete and return the attached Acknowledgement Form to Tosoh Bioscience, Inc., within 15-days of receiving this notification. " In the event of an early degradation of the control material, new controls should be used to verify the instrument performance prior to use. " Maintain this notification with your laboratory records and forward this information to others in your laboratory. " If you have obtained unexpected test results, delays in test result reporting, 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 O'Connell 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: 1000
Distribution: Distributed nationwide. Foreign distribution to Canada.
Product codes and lots: Lot 7055

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0601-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0601-2019	Class III	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-13

Product code LCP

K021484Class IIHemoglobin A1c ControlCanterbury Scientific , Ltd. / cleared 2002-06-14

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)