Bio-Rad Laboratories Inc Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set, Model Number 270-2101NU Manufactured by Bio-Rad Laboratories, Hercules, CA Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set, Model Number 270-2101NU Manufactured by Bio-Rad Laboratories, Hercules, CA
Brand
Bio-Rad Laboratories Inc
Lot Codes / Batch Numbers
Medical device, intended for professional use only.
Products Sold
Medical device, intended for percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography, intended for professional use only.
Bio-Rad Laboratories Inc is recalling Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set, Model Number 27 due to Calibration Failure-- due to high intercept values, the device fails calibration and users are unable to run samples.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Calibration Failure-- due to high intercept values, the device fails calibration and users are unable to run samples.
Recommended Action
Per FDA guidance
Recall initiated June 15, 2009, with notification initially conducted by phone with Fax Notification follow up domestically. Each subsidiary will be given an urgent notice, subsidiary response form, customer notification, customer acknowledgement form. Each subsidiary is to contact customers and translate notification and response form as needed. Contact the recalling firm for additional information.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026