The Recall Desk

Manufacturer

Clinical Diagnostic Solutions

6 recalls in our database name Clinical Diagnostic Solutions as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2014-04-16

Of the 6 recalls from Clinical Diagnostic Solutions we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–6 of 6

  • ModerateFDA (Devices)·Z-1436-2014·2014-04-16

    Clinical Diagnostic Solutions Recalls Hematology Control Material Due to Elevated MCV

    Clinical Diagnostic Solutions is recalling Boule Con-Diff Tri-Level Hematology Control material because of elevated MCV results in specific lots.

    Product
    Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0193-2013·2012-11-14

    Clinical Diagnostic Solutions Recalls Boule Con Diff US Tri Pack Hematology Controls

    Clinical Diagnostic Solutions is recalling Boule Con Diff US Tri Pack hematology controls due to customer reports of inaccurate MCV and RDW% values.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0189-2013·2012-11-14

    Clinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials

    Clinical Diagnostic Solutions is recalling specific lots of Boule Con-Diff Hematology Control vials due to a received complaint.

    Product
    Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
    Category
    Medical Device
    Distribution
    31 states
  • LowFDA (Devices)·Z-0194-2013·2012-11-14

    Clinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials

    Clinical Diagnostic Solutions is recalling Boule Con-Diff hematology control vials because customers reported inaccurate MCV and RDW% values.

    Product
    Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0190-2013·2012-11-14

    Clinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials

    Clinical Diagnostic Solutions is recalling Boule Con-Diff hematology control vials due to a received complaint. The product is used to monitor multi-parameter hematology instruments.

    Product
    Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
    Category
    Medical Device
    Distribution
    31 states
  • LowFDA (Devices)·Z-0191-2013·2012-11-14

    Clinical Diagnostic Solutions Recalls Boule Con-Diff Hematology Control Vials

    Clinical Diagnostic Solutions is recalling Boule Con-Diff hematology control vials due to a received complaint. The product is used to monitor multi-parameter hematology instruments.

    Product
    Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
    Category
    Medical Device
    Distribution
    31 states