Home › ORTHO-CLINICAL DIAGNOSTICS, INC. › VITROS
VITROS
ORTHO-CLINICAL DIAGNOSTICS, INC. · Model 8004707 · UDI-DI 10758750004225
DIH
Prescription
10
510(k) clearances
1
Adverse events
5
Recalls
24
Facilities
Description
VITROS Chemistry Products CHE Slides
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData 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.