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Clinical Diagnostic Solutions Recalls
7 recalls on record · November 14, 2012 to February 12, 2020 · Medical Devices
Recalls by year
12
14
20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 12, 2020Medical DevicesFDA
Clinical Diagnostic Solutions, Inc. recalls Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
Hazard: A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration needle.
April 16, 2014Medical DevicesFDA
Clinical Diagnostic Solutions recalls Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to m
Hazard: Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.
November 14, 2012Medical DevicesFDA
Clinical Diagnostic Solutions recalls Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of mul
Hazard: 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
November 14, 2012Medical DevicesFDA
Clinical Diagnostic Solutions recalls Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-par
Hazard: 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
November 14, 2012Medical DevicesFDA
Clinical Diagnostic Solutions recalls Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parame
Hazard: 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
November 14, 2012Medical DevicesFDA
Clinical Diagnostic Solutions recalls Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parame
Hazard: 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
November 14, 2012Medical DevicesFDA
Clinical Diagnostic Solutions recalls Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parame
Hazard: 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