Home / Recalls / Medical Devices
PerkinElmer Life and Analytical Sciences, Wallac, OY recalls Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing s
Recalled April 19, 2017 · FDA recall Z-1761-2017 · PerkinElmer Life and Analytical Sciences, Wallac, OY
Hazard
Potential for errors in patient results generated by the Specimen Gate Laboratory Software. · FDA Class II
Units
29
Sold at
Worldwide Distribution - US including AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MD, MI, MO, NV, OH, OK, OR, TN, TX, VA; and Internationally to Canada and Brazil
Description
Potential for errors in patient results generated by the Specimen Gate Laboratory Software.
Product
Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.
Manufacturer(s)
PerkinElmer Life and Analytical Sciences, Wallac, OY
Made in
Finland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →