Device recall

Z-1376-06: ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter

FDA device recall · Class II · Bayer Healthcare, LLC (Diagnostics Division)

Key facts

Recall number (Z-number) Z-1376-06
Recall event 35893
Product ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter
Product code GKL
Recalling firm Bayer Healthcare, LLC (Diagnostics Division)
Recall class Class II
Status Terminated
Termination date May 24, 2012
510(k) numbers K971998
FEI number 2432235

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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