Device recall

Z-1366-2018: iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100…

FDA device recall · Class II · Beckman Coulter Inc.

Key facts

Recall number (Z-number) Z-1366-2018
Recall event 79368
Product iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800-3049, 800-3050…
Product code KQO
Recalling firm Beckman Coulter Inc.
Recall class Class II
Status Terminated
Termination date Dec 21, 2022
510(k) numbers K022774
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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