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UF-Fluorocell CR

SYSMEX CORPORATION · Model AG792864 · UDI-DI 04987562433964

GJH Prescription
1
510(k) clearances
1
Adverse events
1
Recalls
22
Facilities

Description

UF-Fluorocell CR is used to mark white blood cells, epithelial cells and bacteria, etc. in urine or in body fluids for determination of their counts with Sysmex fully automated urine particle analyzers. UF-Fluorocell CR is intended for use only in conjunction with Sysmex diluent UF-CELLPACK CR.

Recalls

DateFirmReason
2004-06-24ABX Diagnostics IncPower failure having impact on software.

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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.