Device recall

Z-0061-04: Stat Profile Critical Care Expres Ionized Magnesium Sensor (In-vitro Diagnostic…

FDA device recall · Class II · Nova Biomedical Corporation

Key facts

Recall number (Z-number) Z-0061-04
Recall event 27334
Product Stat Profile Critical Care Expres Ionized Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Critical Care Xpress Analyzer) Part # 37271
Product code CHL
Recalling firm Nova Biomedical Corporation
Recall class Class II
Status Terminated
Termination date Feb 4, 2004
510(k) numbers K022746
FEI number 1219029

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

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

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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