Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic Recalled by Clinical Diagnostic Solutions Due to Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled...

Date: August 4, 2010
Company: Clinical Diagnostic Solutions
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Clinical Diagnostic Solutions directly.

Affected Products

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

Quantity: 690 packs

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Clinical Diagnostic Solutions

Clinical Diagnostic Solutions has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report