FDA recall Z-0210-2020

Product

Beckman Coulter Lipase, REF OSR6130 and OSR6230.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-08-24

Report date

2019-10-30

Termination date

2024-08-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brea, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0210-2020