FDA Enforcement
Class II
Terminated
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.
Recall: Z-1436-2014
·
Reported April 16, 2014
Enforcement
- Recall Number
- Z-1436-2014
- Event ID
- 67724
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Clinical Diagnostic Solutions
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 16, 2014
- Initiation Date
- February 24, 2013
- Classification Date
- April 8, 2014
- Termination Date
- August 7, 2014
- Address
- 1800 Nw 65th Ave Ste 2, N/A, Plantation, FL, 33313-4544, United States
Description
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.
Reason
Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.
Code Info
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
Distribution
Worldwide Distribution: USA Nationwide and the countries of IVORY COAST, MEXICO, and Philippines.
Quantity
3,540