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 For in vitro diagnostic use as Recalled by Clinical Diagnostic Solutions Due to Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled...

Date: March 24, 2011
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 For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

Quantity: 901 vials

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 32 states: AL, AZ, AR, CA, CO, DE, FL, GA, IL, IN, IA, KY, LA, MD, MA, MI, MS, NE, NJ, NY, ND, OH, OK, PA, SC, TN, TX, UT, VA, WV, WI, WY

Affected (32 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