Clinical Diagnostic Solutions: Medical Device Recall in 2014 - (Recall #: Z-1436-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 24, 2013

Date Posted: April 16, 2014

Recall Number: Z-1436-2014

Event ID: 67724

Reason for Recall:

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

Status: Terminated

Product Quantity: 3,540

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.

Voluntary or Mandated:

Voluntary: Firm initiated