NEFA Standard Solution Calibrator, Oleic Acid, 1 mmol/L, 4x10mL bottles per carton, Cat. 276-76491, labeled in part ***F
FDA device recall Z-1071-2007 · posted 2007-07-12 · Terminated
Recall details
- Recalling firm
- Wako Chemicals USA, Inc.
- Reason for recall
- Diagnostic reagent for clinical laboratory testing was incorrectly labeled.
- Action taken
- 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
- Status
- Terminated
- Product code
- JIT
- Quantity affected
- 94 cartons
- Distribution
- Worldwide, including USA, Germany and Canada.
- Date initiated
- 2007-03-30
- Date posted
- 2007-07-12
- Date terminated
- 2007-07-24
- Location
- Richmond, VA
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