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Starch-Dye Bound Polymer, Amylase

FDA product code CIW · Class 2 · Clinical Chemistry

4
Registered devices
0
Adverse events
5
Recalls
8
510(k) clearances

Devices with this code

VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.AU — Beckman Coulter, Inc.AU — Beckman Coulter, Inc.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.

Recent recalls

DateFirmReason
2020-05-11Ortho-Clinical DiagnosticsMultiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on th
2020-05-11Ortho-Clinical DiagnosticsMultiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on th
2020-05-11Ortho-Clinical DiagnosticsMultiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on th
2020-05-11Ortho-Clinical DiagnosticsMultiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on th
2013-06-12Ortho-Clinical DiagnosticsOrtho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.