Recall Z-1901-2010 ยท LCP Assay, Glycosylated Hemoglobin
Bio-Rad Laboratories Inc
VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version 3.5; Model Number: 270-2000; Product is manufactured and distributed by Bio-Rad Laboratories, Diagnostics Group, Hercules, CA. Provides an integrated method for sample preparation, separation and determination of the relative percent of specific hemoglobins in whole blood.
| Date | Jun 25, 2010 (initiated Jan 22, 2009) |
| Status | Terminated |
| Reason | Sample test results for the first run appears to be correct but all subsequent results during that run were assigned incorrect barcode and tube position. |
| Root cause | Software design |
| Action | Bio-Rad Laboratories, Inc. issued and "Urgent: Medical Device Correction" dated January 22, 2009 to all affected consignees by FED EX, followed up by telephone calls for those not responding. Consignees were instructed on proper steps to take in dealing with the affected product. Further communication will follow to provide a solution. For further information, contact Bio-Rad Laboratories at 1-510-724-7000. |
| Distribution | Worldwide Distribution -- United States, Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, Mexico, New Zealand, Poland, Singapore, South Korea, Sweden, Taiwan, Thailand and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984268 | VARIANT II HEMOGLOBIN A1C PROGRAM Bio-Rad, Dec 17, 1998 |