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Terminated

MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.

FDA Recall Z-1377-2018 · Posted 2018-04-13

Recalling FirmCook Inc.
Recall StatusTerminated
Product CodeMQG
Date Initiated2018-01-12
Date Terminated2020-05-08
Product Quantity483

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.

K983642COOK MINI-INCUBATORCook Ob/Gyn · 1999-02-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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