Recall Z-1071-2007 ยท JIT Calibrator, Secondary
Wako Chemicals USA, Inc.
NEFA Standard Solution Calibrator, Oleic Acid, 1 mmol/L, 4x10mL bottles per carton, Cat. 276-76491, labeled in part ***For in vitro diagnostic use ***Distributed by: Wako Chemicals, USA, Inc. 1600 Bellwood Road Richmond, VA 23237***
| Date | Jul 12, 2007 (initiated Mar 30, 2007) |
| Status | Terminated |
| Reason | Diagnostic reagent for clinical laboratory testing was incorrectly labeled. |
| Root cause | Other |
| Action | The recalling firm notified consignees by letter 03/30/07 and advised of labeling error. Consignees were advised that they could return the product for relabeling or affix correct label enclosed with the notification. Distributors were requested to forward notification to end users. The firm subsequently notified consignees on 04/26/07 by fax that product should be returned for label correction. |
| Quantity | 94 cartons |
| Distribution | Worldwide, including USA, Germany and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.