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Z-0191-2013 Class III Terminated

Recalled by Clinical Diagnostic Solutions — Plantation, FL

FDA device recall Z-0191-2013 was initiated by Clinical Diagnostic Solutions on March 24, 2011 and is designated Class III. 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 502-0… The recall status is terminated (terminated August 13, 2014). Affected quantity: 197 vials.

Recall Details

Product Type
Devices
Report Date
November 14, 2012
Initiation Date
March 24, 2011
Termination Date
August 13, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
197 vials

Product Description

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

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

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

Code Information

Product Part 502-012, Lot #1102-574

Other recalls by Clinical Diagnostic Solutions

  • Z-1001-2020 Class II — Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; O (January 2, 2020)
  • Z-1436-2014 Class II — Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for i (February 24, 2013)
  • Z-0190-2013 Class III — Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to (March 24, 2011)
  • Z-0189-2013 Class III — Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to (March 24, 2011)
  • Z-0194-2013 Class III — Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a c (August 4, 2010)
  • Z-0193-2013 Class III — Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control (August 4, 2010)

FDA data resources