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Thermo Scientific Infinity™

Fisher Diagnostics · Model TR50001 · UDI-DI 00845275003239

JGQ
1
510(k) clearances
41
Adverse events
1
Recalls
8
Facilities

Recalls

DateFirmReason
2012-12-19Siemens Healthcare Diagnostics, Inc.Siemens has confirmed an increase on absorbance errors when calibrating Dimension Vista Urinary/Cerebrospinal Fluid Protein (U CFP) Flex Reagent Cartridge lot 11349 BB.

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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.