Home / Recalls / PerkinElmer Life and Analytical Sciences, Wallac, OY / Z-1541-2018

Z-1541-2018 Class II Terminated

Recalled by PerkinElmer Life and Analytical Sciences, Wallac, OY — Turku, N/A

Recall Details

Product Type
Devices
Report Date
May 9, 2018
Initiation Date
November 17, 2017
Termination Date
August 12, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8

Product Description

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.

Reason for Recall

Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.

Distribution Pattern

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

Code Information

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

Other recalls by PerkinElmer Life and Analytical Sciences, Wallac, OY

  • Z-1238-2019 Class II — AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotr (January 10, 2019)
  • Z-1239-2019 Class II — AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotr (January 10, 2019)
  • Z-1237-2019 Class II — DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (January 10, 2019)
  • Z-1692-2018 Class II — NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI (November 2, 2017)
  • Z-1220-2018 Class III — AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the qua (September 25, 2017)
  • Z-1761-2017 Class II — Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is (March 7, 2017)
  • Z-1107-2017 Class II — Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intende (January 5, 2017)
  • Z-1108-2017 Class II — Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro qua (January 5, 2017)