Recall Z-1378-2018 ยท MQG Accessory, Assisted Reproduction
Cook Inc.
MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.
| Date | Apr 13, 2018 (initiated Jan 12, 2018) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| 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 |
| Quantity | 4,451 |
| Distribution | Nationwide (K-IMNC-100 -US G46022) . (K-IMNC-100 G20079 manufactured in Australia and distributed worldwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983642 | COOK MINI-INCUBATOR Cook Ob/Gyn, Feb 1, 1999 |