Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control Recalled by Clinical Diagnostic Solutions Due to Elevated MCV results on the 1311-682, 1311-683, and...

Date: February 24, 2013
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 Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

Quantity: 3,540

Why Was This Recalled?

Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.

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