Z-0191-2013Class III

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

Name: Z-0191-2013 Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of...
Creator: Clinical Diagnostic Solutions
Published: 2011-03-24
License: https://open.fda.gov/license/

Clinical Diagnostic Solutions, Inc. / initiated 2011-03-24 / Terminated / root cause: manufacturing process

FDA source

Clinical Diagnostic Solutions began a recall of Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments on 2011-03-24. FDA classified it as Class III and gives the reason as "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)...". 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-0191-2013
Classification: Class III
Status: Terminated
Initiated: 2011-03-24
Posted: 2012-11-02
Terminated: 2014-08-13
Recalling firm: Clinical Diagnostic Solutions, Inc.
Product: Boule Con-Diff Hematology Control 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 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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Clinical Diagnostic Solutions, Inc. sent a letter dated March 24, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The firm istructed the accounts to replace the assay sheet they were currently using with the new assay sheets enclosed. For an unused product they would need to discard. To correct the ranges in their instrument, they would need to scan in the new bar codes specific for their instrument type. For any questions customers were instructed to contact CDE Technical Support atl 800-453-3328. For questions regarding this recall call 954-791-1773.
Quantity in commerce: 197 vials
Distribution: Worldwide Distribution - USA including AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, ND, ND, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI, WV,and WY. Foreign: Brazil and Colombia
Product codes and lots: Product Part 502-012, Lot #1102-574

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0191-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0189-2013	Class III	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-02
Z-0190-2013	Class III	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-02
Z-0191-2013	Class III	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-02

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)