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Recall Observatory FDA recall evidence

Device product

ABS800 Chemistry Analyzer Part Number BA81F-PA00001, 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-0921-2020

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
6
Official record key
device-enforcement:Z-0921-2020

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 W2-6C000001, W2-6C000002, W2-6C000003, W2-6C000004, W2-6C000005, XP-5B000611T

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.