Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set, Model Number 270-2101NU Manufactured by Bio-Rad Laboratories, Hercules, CA
- Company
- Bio-Rad Laboratories Inc
- Recall Initiated
- June 15, 2009
- Posted
- March 5, 2010
- Terminated
- February 2, 2011
- Recall Number
- Z-1013-2010
- Quantity
- 613 units
- Firm Location
- Hercules, CA
Reason for Recall
Calibration Failure-- due to high intercept values, the device fails calibration and users are unable to run samples.
Distribution
Product was distributed to 127 customers throughout the US and internationally to Argentina, Australia, Canada, Chile, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, New Zealand, Poland, Singapore, Sweden, Taiwan, and the United Kingdom
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.