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

Boule Con Diff US Tri Pack, 6 Vials recalled

Clinical Diagnostic Solutions is recalling Boule Con Diff US Tri Pack, 6 Vials, distributed nationwide in the US. The recall was initiated on 4 Aug 2010 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesProduct part 501-605, Lot #1005-549

Quantity recalled532 packs

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-0193-2013
FDA event ID: 63094
Recalling firm: Clinical Diagnostic Solutions, Plantation, FL
Classification: Class III
Status: Terminated
Recall initiated: 4 Aug 2010
FDA classified: 5 Nov 2012
Reported: 14 Nov 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

4 Aug 2010	Recall initiated by company
5 Nov 2012	Classified by FDA	+824 days
14 Nov 2012	Published in enforcement report	+9 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 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

Product as listed by the FDA

Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Is Boule Con Diff US Tri Pack, 6 Vials recalled?

Yes. Clinical Diagnostic Solutions recalled Boule Con Diff US Tri Pack, 6 Vials on 4 Aug 2010. The recall is Class III and its status is Terminated. Recall number Z-0193-2013.

Why was it recalled?

Which lots are affected?

Product part 501-605, Lot #1005-549

Where was it sold?

Nationwide Distribution.

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 recalled	Clinical Diagnostic Solutions	Other	32 states

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