FDAClass IIOctober 30, 2019

Beckman Coulter Uric Acid recall

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

Why was Beckman Coulter Uric Acid recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots

Product
Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.
Recalling firm
Beckman Coulter Inc.
Quantity
19,834 uits
Distribution
Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada.
Recall date
October 30, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls