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Recall Observatory FDA recall evidence

Device 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))

Z-0920-2020

December 09, 2019

Class II

Product summary

Firm
Mindray DS USA, Inc. dba Mindray North America
Event
Event 84497
Status
Terminated
Classification
Class II
Quantity
7
Official record key
device-enforcement:Z-0920-2020

Official wording

Reason: The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers.

Code information: Serial Numbers: W1-6C000006, W1-71000007, W1-73000009, W1-73000010, XP-68000687T, W1-71000008, W1-85000011

Distribution pattern: The products were distributed to the following US states: MI and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers.