Z-0194-2013Class III

Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the...

Name: Z-0194-2013 Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the...
Creator: Clinical Diagnostic Solutions
Published: 2010-08-04
License: https://open.fda.gov/license/

Clinical Diagnostic Solutions, Inc. / initiated 2010-08-04 / Terminated / root cause: manufacturing process

FDA source

Clinical Diagnostic Solutions began a recall of Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments on 2010-08-04. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0194-2013
Classification: Class III
Status: Terminated
Initiated: 2010-08-04
Posted: 2012-11-05
Terminated: 2014-08-14
Recalling firm: Clinical Diagnostic Solutions, Inc.
Product: Boule Con-Diff Hematology Control 9 vials. 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: 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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Clinical Diagnostic Solutions, Inc. sent a "PRODUCT NOTIFICATION:BOULE CON DIFF TRI-LEVEL LOT 1005-549" letter dated August 4, 2010 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For questions regarding this notice, contact CDS Customer Service at 1-800-453-3328.
Quantity in commerce: 690 packs
Distribution: Nationwide Distribution.
Product codes and lots: Product part 501-607, Lot #1005-549

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0194-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0193-2013	Class III	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-05
Z-0194-2013	Class III	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-05

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)