Clinical Diagnostic Solutions, Inc.
Plantation, FL, US
CLINICAL DIAGNOSTIC SOLUTIONS, INC. appears in FDA device records in Plantation, FL. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Clinical Diagnostic Solutions, Inc. between 1999 and 2004. The busiest year on record is 1999, with 1. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K041130 | CDS HEMATOLOGY CALIBRATOR (CDS CAL) | KRZ | Substantially Equivalent | |
| K024173 | CDS 3-PD HEMATOLOGY CONTROLS | JPK | Substantially Equivalent | |
| K993375 | CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER | KRX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1064130 | 3002684533 | CLINICAL DIAGNOSTIC SOLUTIONS, INC. | 1800 N.W. 65TH AVE., PLANTATION, FL 33313 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KRXCalibrator For Cell Indices
- KRZCalibrator For Hemoglobin And Hematocrit Measurement
- KRYCalibrator For Platelet Counting
- KSACalibrator For Red-Cell And White-Cell Counting
- JCBDetergent
- GIFDiluent, Blood Cell
- OYEFlow Cytometric Reagents And Accessories.
- KIPFormulations, Balanced Salt Solutions
- PPMGeneral Purpose Reagent
- JPKMixture, Hematology Quality Control
- GGKProducts, Red-Cell Lysing Products
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1001-2020 | Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011 | 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. | Class II | Terminated | |
| Z-1436-2014 | 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. | Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots. | Class II | Terminated | |
| Z-0191-2013 | Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. | 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 | Class III | Terminated | |
| Z-0190-2013 | Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. | 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 | Class III | Terminated | |
| Z-0189-2013 | Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. | 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 | Class III | Terminated | |
| Z-0194-2013 | Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. | 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 | Class III | Terminated | |
| Z-0193-2013 | 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. | 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 | Class III | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain