Class III — Low Risk

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

Boule Con Diff US Tri Pack 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 US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

Quantity: 532 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