FDA-Device2019-10-30Class II
Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.
Beckman Coulter Inc.
Hazard
NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.
Sold states
Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada.
Affected count
19,834 uits
Manufactured in
250 S Kraemer Blvd, Brea, CA, United States
Products
Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0211-2020Don't want to check this manually?
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