Recall Z-0376-2007 ยท JIT Calibrator, Secondary
Bio-Rad Laboratories Inc
Bio-Rad D-10 Dual Program Calibrator Diluent, a component of the Bio-Rad D10 Dual Program diagnostic test. This is a specific part of the kit, and only the calibrator diluent is defective. It comes in two kits.
| Date | Jan 25, 2007 (initiated Nov 17, 2006) |
| Status | Terminated |
| Reason | The Diluent in the D-10 Dual Program Calibrator reorder packs is defective, and can cause early calibration failure or elevated control and sample recovery results. |
| Root cause | Other |
| Action | The firm has issued phone calls and faxes to its US consignees starting 11/17/2006 and International notices began on 11/20/2006 explaining the reason for the recall and requesting the product be disposed. |
| Quantity | 900 kits, 43 sets distributed. |
| Distribution | Worldwide, including USA, India, Canada, France, Sweden, the UK, Hong Kong, Singapore, Germany, Brazil, Italy, China, Costa Rica and Panama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041444 | BIO-RAD D-10 DUAL PROGRAM Bio-Rad Laboratories, Inc., Jun 9, 2004 |