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ProciseDx Analyzer
Chembio Diagnostic Systems Inc. · Model 4390 · UDI-DI 08100322943909
10
510(k) clearances
7
Adverse events
17
Recalls
45
Facilities
Description
The ProciseDx Analyzer is intended for use with Procise assay cartridges manufactured by ProciseDx Inc. for the in vitro diagnosis and quantification of various targets or conditions in human patients. The ProciseDx Analyzer should be used in accordance with user documentation and facility specific regulations. For in vitro diagnostic use only.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-14 | Ortho-Clinical Diagnostics, Inc. | Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label. |
| 2024-10-11 | Ortho-Clinical Diagnostics, Inc. | May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples havi |
| 2023-02-01 | Randox Laboratories | The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range |
| 2016-10-26 | Ortho-Clinical Diagnostics | CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent Pack 3, or a sample with a low concentration of CRP had positively biase |
| 2013-06-12 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
| 2013-05-09 | Ortho-Clinical Diagnostics | While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amount of surfactant was unintentionally added to VITROS Chemistry Products CRP Slides |
| 2013-03-06 | Alere San Diego, Inc. | The Alere Cholestech LDX hsCRP cassette (PN 12-807) may have increased imprecision relative to the performance data in the package insert, which may cause differences in quantitati |
| 2009-07-21 | Medtest Holdings, Inc. | Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are incorrectly listed as mg/dl when the correct unit is mg/L. |
| 2009-05-01 | Kamiya Biomedical Company, LLC | The long-term stability of level 2 (1.0 mg/dL) may not be within the specifications due to a decrease in CRP concentration. |
| 2008-01-10 | Beckman Coulter Inc | IMMAGE CRP Reagent lots M705441, M709279, & M709319, may demonstrate a prozone or hook effect on samples with extremely high CRP analyte concentration. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.