FDA-Device2019-10-30Class II
Beckman Coulter Lipase, REF OSR6130 and OSR6230.
Beckman Coulter Inc.
Hazard
NAPQI, a metabolite of Acetaminophen, 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
20,926 units
Manufactured in
250 S Kraemer Blvd, Brea, CA, United States
Products
Beckman Coulter Lipase, REF OSR6130 and OSR6230.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0210-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief