PerkinElmer Life and Analytical Sciences, Wallac, OY

Clinical Chemistry and Clinical Toxicology Devices

1

No

MA, SC, TX, AL OUS: China, Mexico, Peru, Morocco, Italy, Finland, Ecuador, Brazil

Spare Disk Remover Module; Product Number: 61001820 || Intended for in vitro quantitative and qualitative determination of analytes in body fluids.

Serial Numbers: 20210239 20210243 20210244 20210245 20210246 20210247 20210248 20210249 20210250 20210251 20210252 20210253 20210254 20210255 20210256 20210257 20210258 20210259 20210260 20210261 20210262 20210263 20210264 20210265

Clinical Chemistry and Clinical Toxicology Devices

1

No

MA, SC, TX, AL OUS: China, Mexico, Peru, Morocco, Italy, Finland, Ecuador, Brazil

Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 || Intended for in vitro quantitative and qualitative determination of analytes in body fluids.

Software Version: 1.3 Rev2, 1.7, 1.8, 1.9, 1.9 Rev2

Clinical Chemistry and Clinical Toxicology Devices

1

No

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

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.

Affected lots: 654184 653414 653657 654923 655680 655300 654924 656025 657055 656170 656320 657768 657513 658006

Clinical Chemistry and Clinical Toxicology Devices

2

No

Distributed in 20 US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MO, NV, OH, OR, SC, TN, TX.

NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 || (01)06438147295708(17)180531(10)653414 || (01)06438147295708(17)180531(10)653657 || (01)06438147295708(17)180630(10)654923 || (01)06438147295708(17)180630(10)655680 || (01)06438147295708(17)180630(10)655300 || (01)06438147295708(17)180630(10)654924 || (01)06438147295708(17)180831(10)656025 || (01)06438147295708(17)180831(10)657055 || (01)06438147295708(17)180831(10)656170 || (01)06438147295708(17)180831(10)656320 || (01)06438147295708(17)181031(10)657768 || (01)06438147295708(17)181031(10)657513 || (01)06438147295708(17)181031(10)658006

All software versions from 1.0 to 1.8 (current software version)

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - US Distribution to the state of Georgia., and to the countries of : Belgium, Canada, Denmark, Italy, and United Kingdom.

Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) || Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.