Recall Z-1013-2010 ยท LCP Assay, Glycosylated Hemoglobin
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
| Date | Mar 5, 2010 (initiated Jun 15, 2009) |
| Status | Terminated |
| Reason | Calibration Failure-- due to high intercept values, the device fails calibration and users are unable to run samples. |
| Root cause | Other |
| Action | 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. |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070452 | VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU Bio-Rad Laboratories, Inc., May 7, 2007 |