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.
Reason for recall: 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. Distribution: 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 Quantity: 34 units Lot/code info: Unknown product distributed in India and Australia as lab equipment. Version or Model: Multiple/unknown; Primary DI Number: unknown; Serial Numbers: unknown. NOTE: These devices are one of the five (5) noted affected Part Numbers, so the intended use, etc. will be one of those other devices. As stated above, traceability was not a concern due to the classification of these devices in those regions.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.