Home / Recalls / PerkinElmer Life and Analytical Sciences, Wallac, OY / Z-1237-2019

Z-1237-2019 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
May 8, 2019
Initiation Date
January 10, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
31 kits (10 in US, 21 in ROW)

Product Description

DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.

Reason for Recall

hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.

Distribution Pattern

Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.

Code Information

Kit Lot Numbers: 664891, 666471, 666604 Pack Lot Numbers: 1066489101, 1066647101,1066660401 UDI: (01)06438147009176(17)190430(10)664891 (01)06438147009176(17)190430(10)666471 (01)06438147009176(17)190430(10)666604

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

  • Z-1239-2019 Class II — AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotr (January 10, 2019)
  • Z-1238-2019 Class II — AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotr (January 10, 2019)
  • Z-1541-2018 Class II — Specimen Gate Screening Center, Part Number 5002-0500, All software versions fro (November 17, 2017)
  • 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)