Device Recall Specimen Gate Laboratory 의 리콜

Recall

76648

Class 2

Z-1761-2017

2017-03-07

2017-03-13

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153750

Potential for errors in patient results generated by the specimen gate laboratory software.

PerkinElmer Life and Analytical Sciences sent an Urgent Medical Device Correction letter dated March 7, 2017, to all affected consignees. The letter contains the following instructions: Until PerkinElmer's corrective measures are completed, we request our customers to close the Specimen Gate Laboratory Result Viewer between viewing and especially between manually calculating assay results. Closing and reopening the Result Viewer between processing the results from different assays effectively prevents the described issues from occurring. We also request our customers to follow unreported specimens with available tools to avoid any delay in reporting screening results. The available tools will vary depending on their process or the LIMS system that is used for activities associated with management of patient demographics, patient reports and the overall management of data generated from newborn screening testing. The final corrective action will involve an installation update to the software. PerkinElmer will deploy an installation update that will prevent the described issue when assays are calculated during the same Result Viewer session without closing it between the processing of different assays. Once the installation update is available, Software Services will contact you and arrange for the deployment. The installation update will be provided to you free of charge. Customers were instructed to complete the enclosed response form and return it by fax to 1-330-825-8520 (US) =358 2 2678 357 (OUS). For questions regarding this recall call 317-418-1735.