Z-1436-2014Class II

Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a...

Name: Z-1436-2014 Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a...
Creator: Clinical Diagnostic Solutions
Published: 2013-02-24
License: https://open.fda.gov/license/

Clinical Diagnostic Solutions, Inc. / initiated 2013-02-24 / Terminated

FDA source

Clinical Diagnostic Solutions began a recall of Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of... on 2013-02-24. FDA classified it as Class II and gives the reason as "Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1436-2014
Classification: Class II
Status: Terminated
Initiated: 2013-02-24
Posted: 2014-04-09
Terminated: 2014-08-07
Recalling firm: Clinical Diagnostic Solutions, Inc.
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.
Product code: JPK Mixture, Hematology Quality Control
Reason for recall: Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.
FDA root cause: Under Investigation by firm
Action: Clinical Diagnostic Solutions sent a Notification letter dated February 26, 2014 to affected customers. The letter identified the affected product, problem and the actions to be taken. For questions contact Technical Support at 1-800-453-3328.
Quantity in commerce: 3,540
Distribution: Worldwide Distribution: USA Nationwide and the countries of IVORY COAST, MEXICO, and Philippines.
Product codes and lots: Product Part Number: 501-605 Lot# 1311-682 Exp. 3/26/2014 501-607 Lot# 1311-683, 1311-684 Exp. 3/26/2014 501-608 Lot# 1311-683 Exp. 3/26/2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1436-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1436-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-08

Product code JPK

K024173Class IICds 3-Pd Hematology ControlsClinical Diagnostic Solutions, Inc. / cleared 2003-01-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)