Home › Device types › DIH
Colorimetry, Cholinesterase
FDA product code DIH · Class 1 · Clinical Toxicology
32
Registered devices
1
Adverse events
5
Recalls
26
510(k) clearances
Devices with this code
Cholinesterase Gen.2 — Roche Diagnostics GmbHBUTYRYL CHOLINESTERASE (CHE) — RANDOX LABORATORIES LIMITEDBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.AChE Assay Kit — Eqm Research, Inc.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Atellica CH Cholinesterase_2 — Siemens Healthcare Diagnostics Inc.ADVIA® Chemistry CHE Cholinesterase Reagents — Siemens Healthcare Diagnostics Inc.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.Teco Diagnostics Cholinesterase Reagent Set — TECO DIAGNOSTICSCholinesterase Gen.2 — Roche Diagnostics GmbHCholinesterase — Roche Diagnostics GmbHBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.Dimension Vista® Flex® reagent cartridge PCHE — Siemens Healthcare Diagnostics Inc.Test-mate ChE Cholinesterase Test System — Eqm Research, Inc.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.AU — Beckman Coulter, Inc.ADVIA® Chemistry CHE Cholinesterase Reagents — Siemens Healthcare Diagnostics Inc.BUTYRYL CHOLINESTERASE (CHE) — RANDOX LABORATORIES LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-10 | Ortho-Clinical Diagnostics, Inc. | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs |
| 2025-06-10 | Ortho-Clinical Diagnostics, Inc. | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs |
| 2025-06-10 | Ortho-Clinical Diagnostics, Inc. | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs |
| 2025-06-10 | Ortho-Clinical Diagnostics, Inc. | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs |
| 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. |
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