Device recall

Z-0920-2020: BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003…

FDA device recall · Class II · Mindray DS USA, Inc. dba Mindray North America

Key facts

Recall number (Z-number) Z-0920-2020
Recall event 84497
Product BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))
Product code JGS
Recalling firm Mindray DS USA, Inc. dba Mindray North America
Recall class Class II
Status Terminated
Termination date Sep 17, 2020
510(k) numbers K160370
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

Browse all FDA device recalls (products)