Device recall

Z-0101-2014: HemoCue Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes…

FDA device recall · Class II · HemoCue AB

Key facts

Recall number (Z-number) Z-0101-2014
Recall event 65920
Product HemoCue Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden
Product code GKR
Recalling firm HemoCue AB
Recall class Class II
Status Terminated
Termination date Aug 11, 2014
510(k) numbers K032203
FEI number 3003044483

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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