Home / Recalls / Clinical Diagnostic Solutions / Z-1436-2014

Z-1436-2014 Class II Terminated

Recalled by Clinical Diagnostic Solutions — Plantation, FL

Recall Details

Product Type
Devices
Report Date
April 16, 2014
Initiation Date
February 24, 2013
Termination Date
August 7, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,540

Product 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 for Recall

Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.

Distribution Pattern

Worldwide Distribution: USA Nationwide and the countries of IVORY COAST, MEXICO, and Philippines.

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

Other recalls by Clinical Diagnostic Solutions

  • Z-1001-2020 Class II — Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; O (January 2, 2020)
  • Z-0189-2013 Class III — Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to (March 24, 2011)
  • Z-0190-2013 Class III — Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to (March 24, 2011)
  • Z-0191-2013 Class III — Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to (March 24, 2011)
  • Z-0193-2013 Class III — Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control (August 4, 2010)
  • Z-0194-2013 Class III — Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a c (August 4, 2010)