Recall Z-1013-2010
Bio-Rad Laboratories Inc · initiated June 15, 2009
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
Codes / lots: 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.
Reason for recall
Calibration Failure-- due to high intercept values, the device fails calibration and users are unable to run samples.
FDA-determined 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.
Details
- Recall number
- Z-1013-2010
- Initiated
- June 15, 2009
- Posted by FDA
- March 5, 2010
- Terminated
- February 2, 2011
- Product code
- LCP – Assay, Glycosylated Hemoglobin
- Quantity
- 613 units
- 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
- Recalling firm
- Bio-Rad Laboratories Inc, Hercules, CA