Device recall

Z-0954-2009: LIGHT DIAGNOSTICS Simulfluor Flu A / Flu B 2 mL Reagent Catalog # 5250 which is…

FDA device recall · Class II · Millipore Corporation

Key facts

Recall number (Z-number) Z-0954-2009
Recall event 50511
Product LIGHT DIAGNOSTICS Simulfluor Flu A / Flu B 2 mL Reagent Catalog # 5250 which is a component in the Kit Catalog #3121 Simulfluor Flu A / Flu B DFA kit.
Product code GNW
Recalling firm Millipore Corporation
Recall class Class II
Status Terminated
Termination date Aug 10, 2012
510(k) numbers K974302
FEI number 2024094

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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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