FDAFDA · Food and drugs·Recall number Z-0194-2013
Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Published November 14, 2012 · Recall initiated: August 4, 2010
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
Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part 501-605, Lot #1005-549 and Product part 501-607, Lot #1005-549) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was imitated due to receipt of customers stating the MCV values and RDW% recovered for Boule
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Clinical Diagnostic Solutions
- Distributor
- Nationwide Distribution.
- Lot
- Product part 501-607, Lot #1005-549
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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