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ARUM DENTISTRY Co., Ltd. · Model Arum-WR-28-C2 · UDI-DI 08800055732985

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510(k) clearances

Adverse events

Recalls

Facilities

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.