Device product
MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.
Z-1377-2018
Product summary
- Firm
- Cook Inc.
- Event
- Event 79711
- Status
- Terminated
- Classification
- Class II
- Quantity
- 483
- Official record key
device-enforcement:Z-1377-2018
Official wording
Reason: 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.
Code information: All lots
Distribution pattern: Nationwide (K-IMNC-100 -US G46022) . (K-IMNC-100 G20079 manufactured in Australia and distributed worldwide)
Derived failure modes
-
Unknown
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.