Device recall

Z-0601-2012: Coulter HmX Hematology Analyzer with Autoloader, Part number: 6605525, 6605526…

FDA device recall · Class II · Beckman Coulter Inc.

Key facts

Recall number (Z-number) Z-0601-2012
Recall event 60367
Product Coulter HmX Hematology Analyzer with Autoloader, Part number: 6605525, 6605526, 6605527. HmX Hematology Analyzer / HmX Hematology Analyzer with Autoloader PN 4237523 Rev C. The COULTER HmX Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter…
Product code GKZ
Recalling firm Beckman Coulter Inc.
Recall class Class II
Status Terminated
Termination date Jun 1, 2012
510(k) numbers K010765
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

Browse all FDA device recalls (products)