Device recall

Z-0720-2021: MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of…

FDA device recall · Class II · Beckman Coulter Inc.

Key facts

Recall number (Z-number) Z-0720-2021
Recall event 86817
Product MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic cocci and listeria monocytogenes.
Product code LRG
Recalling firm Beckman Coulter Inc.
Recall class Class II
Status Terminated
Termination date Jan 3, 2023
510(k) numbers K043545
FEI number 2050012

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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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