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Recall Observatory FDA recall evidence

Device product

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

Z-0190-2013

March 24, 2011

Class III

Product summary

Firm
Clinical Diagnostic Solutions
Event
Event 63096
Status
Terminated
Classification
Class III
Quantity
901 vials
Official record key
device-enforcement:Z-0190-2013

Official wording

Reason: 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

Code information: Product Part 501-607, Lot #1102-576

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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