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PerkinElmer Life and Analytical Sciences, Wallac, OY Recalls
9 recalls on record · February 8, 2017 to May 8, 2019 · Medical Devices
Recalls by year
17
18
19
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 8, 2019Medical DevicesFDA
PerkinElmer Life and Analytical Sciences, Wallac, OY recalls AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Pro
Hazard: hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
May 8, 2019Medical DevicesFDA
PerkinElmer Life and Analytical Sciences, Wallac, OY recalls AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Pro
Hazard: hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
May 8, 2019Medical DevicesFDA
PerkinElmer Life and Analytical Sciences, Wallac, OY recalls DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product
Hazard: hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
September 12, 2018Medical DevicesFDA
PerkinElmer Life and Analytical Sciences, Wallac, OY recalls AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunor
Hazard: The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information required to assess the acceptability of measured control values which may result in a delay in reporting IRT results.
May 16, 2018Medical DevicesFDA
PerkinElmer Life and Analytical Sciences, Wallac, OY recalls NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10
Hazard: There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instructed, a transient minor allergic skin reaction may result when handling leaking succinylacetone reagent vials.
May 9, 2018Medical DevicesFDA
PerkinElmer Life and Analytical Sciences, Wallac, OY recalls Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version)
Hazard: Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.
April 19, 2017Medical DevicesFDA
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
Hazard: Potential for errors in patient results generated by the Specimen Gate Laboratory Software.
February 8, 2017Medical DevicesFDA
PerkinElmer Life and Analytical Sciences, Wallac, OY recalls Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro quantitative and qualitative determination
Hazard: The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditions, there is a risk that the axle material will corrode. Deterioration of the axle can be observed as deposits of corrosion on the defective axles. Ball bushing axles may corrode and corrosion particle may cause contamination in the wells or the corrosion will cause movement issues and possibly spillage and causing contamination of the plate wells.
February 8, 2017Medical DevicesFDA
PerkinElmer Life and Analytical Sciences, Wallac, OY recalls Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitat
Hazard: The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditions, there is a risk that the axle material will corrode. Deterioration of the axle can be observed as deposits of corrosion on the defective axles. Ball bushing axles may corrode and corrosion particle may cause contamination in the wells or the corrosion will cause movement issues and possibly spillage and causing contamination of the plate wells.