FDA recall Z-0862-2023

Product

ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013

Reason for recall

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2022-11-09

Report date

2023-01-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hazelwood, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0862-2023