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Recall Observatory FDA recall evidence

Device product

Beckman Coulter Lipase, REF OSR6130 and OSR6230.

Z-0210-2020

August 24, 2018

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 83583
Status
Terminated
Classification
Class II
Quantity
20,926 units
Official record key
device-enforcement:Z-0210-2020

Official wording

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