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PChE Assay Kit

Eqm Research, Inc. · Model 470 · UDI-DI 00860010612224

510(k) clearances

Adverse events

Recalls

Facilities

Description

For the quantitative determination of Plasma Cholinesterase in whole blood to monitor pesticide exposure. For in vitro diagnostic use. For laboratory use by trained laboratory technicians only. For use only with the Test-mate ChE Cholinesterase Test System (Model 400). Contains materials for 96 tests.

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 when the PVs are use
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 when the PVs are use
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 when the PVs are use
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 when the PVs are use
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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Data 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.