Clinical Diagnostic Solutions: Medical Device Recall in 2012 - (Recall #: Z-0194-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

Product Classification:

Class III

Date Initiated: August 4, 2010

Date Posted: November 14, 2012

Recall Number: Z-0194-2013

Event ID: 63094

Reason for Recall:

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

Status: Terminated

Product Quantity: 690 packs

Code Information:

Product part 501-607, Lot #1005-549

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated