Recall Z-1041-2009 ยท LCP Assay, Glycosylated Hemoglobin
Bio-Rad Laboratories Inc
Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600, Manufactured by Bio-Rad Laboratories, Hercules, CA Provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood. This device only tests for A 1 c.
| Date | Mar 24, 2009 (initiated Oct 17, 2008) |
| Status | Terminated |
| Reason | Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results. |
| Root cause | Pending |
| Action | An Urgent Medical Device Correction letter was sent out on October 17, 2008 via fax and phone call. The letter recommended that customers review the Summary Report for duplicate tube position numbers or barcode IDs within the same rack. If there are questions or a need for assistance, customers are to contact their regional Bio-Rad office. Follow-ups will be made once root cause is identified. |
| Quantity | 92 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063400 | VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 Bio-Rad Laboratories, Inc., Dec 1, 2006 |