Recall Z-1436-2014— Clinical Diagnostic Solutions

Name: FDA recall Z-1436-2014
Creator: U.S. Food and Drug Administration
Published: 2013-02-24

Class II · Terminated

Class II FDA medical device recall by Clinical Diagnostic Solutions, initiated 2013-02-24, terminated 2014-08-07. It names one FDA 510(k) clearance: K024173. Product: 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.. Reason: Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots..

Recalling firm: Clinical Diagnostic Solutions
Classification: Class II
Status: Terminated
Initiated: 2013-02-24
Terminated: 2014-08-07
Firm location: Plantation, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K024173 — CDS 3-PD HEMATOLOGY CONTROLSClinical Diagnostic Solutions, Inc.·cleared 2003-01-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.