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Harioculture TL-16 Time-lapse Incubator
Hua Yue Medical Technology Co., Ltd. · Model Harioculture TL-16 · UDI-DI 06975183900185
1
510(k) clearances
11
Adverse events
9
Recalls
24
Facilities
Description
Time-lapse Incubator provides an environment with controlled temperature and gas concentrations (CO2 and O2) or mixed gas (CO2 and other gases) for the development of embryos at or near body temperature. Use of the Time-lapse Incubator is limited to five days (120 hr) covering the time from post insemination to day five of development.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-07 | Cook Medical Llc | The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static electricity) is applied to the lid of the device. This may lead to embryo degenerat |
| 2022-08-12 | CooperSurgical, Inc. | There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the steri |
| 2022-08-12 | CooperSurgical, Inc. | There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the steri |
| 2020-12-16 | Cook Medical Llc | A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause the silicone stoppers to dislodge or gas to leak from the flasks, impeding |
| 2019-09-05 | CooperSurgical, Inc. | The touchpad may not work properly after cleaning. |
| 2018-03-22 | Cook Inc. | Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to |
| 2018-03-22 | Cook Inc. | Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to |
| 2018-01-12 | Cook Inc. | 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 l |
| 2018-01-12 | Cook Inc. | 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 l |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.