CLASS III Device recall · Reported 14 Nov 2012 · FDA Enforcement Report

Boule Con-Diff Hematology Control recalled

Clinical Diagnostic Solutions is recalling Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the, distributed in 32 states. The recall was initiated on 24 Mar 2011 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesProduct Part 501-607, Lot #1102-576

Quantity recalled901 vials

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0190-2013
FDA event ID: 63096
Recalling firm: Clinical Diagnostic Solutions, Plantation, FL
Classification: Class III
Status: Terminated
Recall initiated: 24 Mar 2011
FDA classified: 2 Nov 2012
Reported: 14 Nov 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

24 Mar 2011	Recall initiated by company
2 Nov 2012	Classified by FDA	+589 days
14 Nov 2012	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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

Where it was distributed

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

Alabama Arkansas Arizona California Colorado Delaware Florida Georgia Iowa Illinois Indiana Kentucky Louisiana Massachusetts Maryland Michigan Mississippi North Dakota Nebraska New Jersey

Questions about this recall

Is Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the recalled?

Yes. Clinical Diagnostic Solutions recalled Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the on 24 Mar 2011. The recall is Class III and its status is Terminated. Recall number Z-0190-2013.

Why was it recalled?

Which lots are affected?

Product Part 501-607, Lot #1102-576

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Reported	Class	Recall	Company	Reason	Where
12 Feb 2020Device	CLASS II	Medonic M-Series Hematology Analyzer M16S BD ABR US Product recalled	Clinical Diagnostic Solutions	Packaging Defects	Nationwide
16 Apr 2014Device	CLASS II	Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology recalled	Clinical Diagnostic Solutions	Potency & Assay	Nationwide
14 Nov 2012Device	CLASS III	Boule Con-Diff Hematology Control recalled	Clinical Diagnostic Solutions	Other	32 states
14 Nov 2012Device	CLASS III	Boule Con-Diff Hematology Control recalled	Clinical Diagnostic Solutions	Other	32 states
14 Nov 2012Device	CLASS III	Boule Con-Diff Hematology Control 9 vials recalled	Clinical Diagnostic Solutions	Other	Nationwide

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