Clinical Diagnostic Solutions: Medical Device Recall in 2012 - (Recall #: Z-0191-2013)

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 For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

Product Classification:

Class III

Date Initiated: March 24, 2011

Date Posted: November 14, 2012

Recall Number: Z-0191-2013

Event ID: 63096

Reason for Recall:

Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complai

Status: Terminated

Product Quantity: 197 vials

Code Information:

Product Part 502-012, Lot #1102-574

Distribution Pattern:

Worldwide Distribution - USA including AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, ND, ND, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI, WV,and WY. Foreign: Brazil and Colombia

Voluntary or Mandated:

Voluntary: Firm initiated