Device recall

Z-0977-2013: BS-200 Chemistry Analyzer Designed for clinical laboratory use.

FDA device recall · Class II · Mindray DS USA, Inc. d.b.a. Mindray North America

Key facts

Recall number (Z-number) Z-0977-2013
Recall event 64112
Product BS-200 Chemistry Analyzer Designed for clinical laboratory use.
Product code CFR
Recalling firm Mindray DS USA, Inc. d.b.a. Mindray North America
Recall class Class II
Status Terminated
Termination date Jun 12, 2013
510(k) numbers K022519
FEI number 2221819

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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