Phadia Ab Recalls
5 recalls on record · February 3, 2016 to January 31, 2024 · Medical Devices
Recalls by year
16
18
19
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 31, 2024Medical DevicesFDA
Phadia Ab recalls EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Hazard: Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen.
September 4, 2019Medical DevicesFDA
Phadia Ab recalls Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument includin
Hazard: code 7-102 Liquid Sensor Error
July 10, 2019Medical DevicesFDA
Phadia Ab recalls EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measur
Hazard: Potential for reporting low assay results
April 11, 2018Medical DevicesFDA
Phadia Ab recalls Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number
Hazard: We want to inform all Phadia 250 system operators performing EliA Assays not to use the function OK to All in any version of Phadia Prime, up to and including 2.1.4, when rejecting and retesting samples with any EliA assay (the OK function may be used for rejecting single tests and dilution of samples in accordance with product DfU).
February 3, 2016Medical DevicesFDA
Phadia Ab recalls EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative me
Hazard: All equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmDP well lot 0018 may be incorrect and must be considered invalid. Patient samples in complaint investigations caused unspecific signals up to 22 U/ml on EliA SmDP well lot 0018. The nonspecific signals are not caused by anti-Sm antibodies, nor by streptavidin antibodies.