MAUDE report

MAUDE report 54208: CELL-DYN 1600 CS

Other · received Dec 6, 1996 · ABBOTT DIAGNOSTICS DIV/CELL DYN

Key facts

MDR report key 54208
Report number 2919069-1996-00002
Event type Other
Brand name CELL-DYN 1600 CS
Model number NI
Catalog number 91374-01
Manufacturer ABBOTT DIAGNOSTICS DIV/CELL DYN
Product code GKZ
Device class Class II
Date received by FDA Dec 6, 1996
Report date Dec 5, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 1–9 MAUDE reports for this brand
  • None Death reports for this brand
  • None Injury reports for this brand
  • Yes Adverse event flagged
  • No Product problem flagged

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE medical device reports

MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.

Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date:

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