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***
FDA Recall Z-1071-2007 · Posted 2007-07-12
Recalling FirmWako Chemicals USA, Inc.
Recall StatusTerminated
Product CodeJIT
Date Initiated2007-03-30
Date Terminated2007-07-24
Product Quantity94 cartons
Reason for Recall
Diagnostic reagent for clinical laboratory testing was incorrectly labeled.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Germany and Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.