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Elecsys PlGF
Roche Diagnostics GmbH · Model 09015434190 · UDI-DI 07613336172124
QWH
Prescription
1
510(k) clearances
2
Adverse events
1
Recalls
3
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-12 | Brahms GmbH | Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which require troubleshooting steps to resolve. If |
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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.