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Atellica CH CHE

Siemens Healthcare Diagnostics Inc. · Model 11097615 · UDI-DI 00630414596273

DIH
1
510(k) clearances
1
Adverse events
5
Recalls
24
Facilities

Description

Cholinestrase (CHE) Atellica CH - RGT 270T

Recalls

DateFirmReason
2025-06-10Ortho-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
2025-06-10Ortho-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
2025-06-10Ortho-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
2025-06-10Ortho-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
2013-06-12Ortho-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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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.