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Recall Observatory FDA recall evidence

Device product

Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.

Z-0211-2020

August 24, 2018

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 83583
Status
Terminated
Classification
Class II
Quantity
19,834 uits
Official record key
device-enforcement:Z-0211-2020

Official wording

Reason: NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.

Code information: All lots

Distribution pattern: Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.