FDA recall Z-1378-2018

Cook Inc. · Class II · device

Product

MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.

Reason for recall

The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex lid heater.

Distribution

Nationwide (K-IMNC-100 -US G46022) . (K-IMNC-100 G20079 manufactured in Australia and distributed worldwide)

Key facts

Status: Terminated
Initiation date: 2018-01-12
Report date: 2018-04-25
Termination date: 2020-05-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1378-2018