Device product
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.
Z-1436-2014
Product summary
- Event
- Event 67724
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,540
- Official record key
device-enforcement:Z-1436-2014
Official wording
Reason: Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.
Code information: 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 pattern: Worldwide Distribution: USA Nationwide and the countries of IVORY COAST, MEXICO, and Philippines.
Derived failure modes
-
Unknown
Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.