Recall Z-0536-2007 ยท JIX Calibrator, Multi-Analyte Mixture
Diagnostic Chemicals, Ltd.
Microalbumin Multi-Calibrator Set, in vitro diagnostic. Catalog Number: SE-252
| Date | Feb 27, 2007 (initiated Sep 6, 2006) |
| Status | Terminated |
| Reason | Microalbumin Multi Calibrator mislabeled label on Level 5 and Level 6, cap label correct |
| Root cause | Other |
| Action | Diagnostic Chemicals Ltd, Canada notified customers by telephone and fax on 9/06/06 and advised to use the cap label to determine concentration of the calibrators. Accounts were asked to confirm and acknowledge receipt of the letter. |
| Quantity | 38 kits |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042243 | MICROALBUMIN MULTI-CALIBRATOR SET Diagnostic Chemicals , Ltd., Oct 4, 2004 |