FDAFDA · Food and drugs·Recall number Z-1436-2014
Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Published April 16, 2014 · Recall initiated: February 24, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Clinical Diagnostic Solutions
- Distributor
- Worldwide Distribution: USA Nationwide and the countries of IVORY COAST, MEXICO, and Philippines.
- Lot
- Product Part Number: 501-605 Lot# 1311-682 Exp. 3/26/2014 501-607 Lot# 1311-683, 1311-684 Exp. 3/26/2014 501-608 Lot# 1311-683 Exp. 3/26/2014
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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