Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.

Recall Insight

This FDA Devices action (record #Z-0601-2019) was formally reported on December 19, 2018, with the manufacturer initiating the action on October 5, 2018. It is classified under Low severity (Class III), with a current status of Terminated. Tosoh Bioscience Inc is listed as the recalling firm, operating out of Grove City, OH. Federal records indicate 1000 units are affected.

The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: Distributed nationwide. Foreign distribution to Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 8 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.