Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

Reason: The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.

Code information: Version or Model: K22074; Primary DI Number: 00888937025057; Serial Numbers: 2244KH01 , 2244KH02 , 2244KH03 , 2244KH04 , 2244KH05 , 2244KH06 , 2244KH07 , 2244KH08 , 2244KH09 , 2244KH10 , 2313KH01 , 2313KH02 , 2313KH03 , 2313KH04 , 2313KH05 , 2313KH06 , 2313KH07 , 2313KH08 , 2313KH09 , 2313KH10 , 2320KH21 , 2320KH22 , 2320KH23 , 2320KH24 , 2320KH25 , 2320KH26 , 2320KH27 , 2320KH28 , 2320KH29 , 2320KH30 , 2321KH16 , 2321KH17 , 2321KH18 , 2321KH19 , 2321KH20,

Distribution pattern: States: NC, NJ, TX, VA, IL, NY, CA, PA Please note: The countries below, excluding Iraq, all consider these devices to be "lab equipment", not medical devices and are not subject to classification or recall guidelines. Countries: AT, AU, BE, BH, BR, CA, CH, CN, CZ, DE, EG, ES, ET, FR, GB, GH, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, MA, MK, MT, NL, NO, PE, PH, PK, PT, QA, RO, RS, SA, SD, SE, SO,TR, TW, TZ, US, ZA