MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.
FDA Recall Z-1378-2018 · Posted 2018-04-13
Recalling FirmCook Inc.
Recall StatusTerminated
Product CodeMQG
Date Initiated2018-01-12
Date Terminated2020-05-08
Product Quantity4,451
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.
Firm Action
Cook plans to begin notifying consignees of the recall on January 12, 2018
Written recall communication letters will be mailed via courier to US consignees
Root Cause
Device Design
Distribution Pattern
Nationwide (K-IMNC-100 -US G46022) . (K-IMNC-100 G20079 manufactured in Australia and distributed worldwide)
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.