Device recall

Z-1433-04: COULTER LH 500 Hematology Analyzer part numbers: 178832, 178833, and 178834…

FDA device recall · Class II · Beckman Coulter Inc

Key facts

Recall number (Z-number) Z-1433-04
Recall event 29880
Product COULTER LH 500 Hematology Analyzer part numbers: 178832, 178833, and 178834 software versions 1A and 1A2. The LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH %500 Analyzer also…
Product code GKZ
Recalling firm Beckman Coulter Inc
Recall class Class II
Status Terminated
Termination date Apr 26, 2012
510(k) numbers K032000
FEI number 2050012

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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