Recalls / —
—#163146
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.
- FDA product code
- MQG — Accessory, Assisted Reproduction
- Device class
- Class 2
- Medical specialty
- Obstetrics/Gynecology
- 510(k) numbers
- K983642
- Affected lot / code info
- All lots
Why it was recalled
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.
Root cause (FDA determination)
Device Design
Action the firm took
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
Recalling firm
- Firm
- Cook Inc.
- Address
- 750 N Daniels Way, Bloomington, Indiana 47404-9120
Distribution
- Distribution pattern
- Nationwide (K-IMNC-100 -US G46022) . (K-IMNC-100 G20079 manufactured in Australia and distributed worldwide)
Timeline
- Recall initiated
- 2018-01-12
- Posted by FDA
- 2018-04-13
- Terminated
- 2020-05-08
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #163146. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.