Phadia US Recalls
9 recalls on record · September 5, 2012 to July 5, 2023 · Medical Devices
Recalls by year
12
15
17
18
21
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 5, 2023Medical DevicesFDA
Phadia US Inc recalls Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin
Hazard: Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument
July 5, 2023Medical DevicesFDA
Phadia US Inc recalls EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is intended for t
Hazard: Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument
February 17, 2021Medical DevicesFDA
Phadia US Inc recalls EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA
Hazard: Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results (increase in patient test results).
April 11, 2018Medical DevicesFDA
Phadia US Inc recalls ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP Specific IgE is an in vitro quantitative
Hazard: The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met.
April 11, 2018Medical DevicesFDA
Phadia US Inc recalls ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative as
Hazard: The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.
January 24, 2018Medical DevicesFDA
Phadia US Inc recalls Phadia 1000 Instrument, Article Number 12-3800-01.
Hazard: The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.
March 8, 2017Medical DevicesFDA
Phadia US Inc recalls EliA Sample Diluent, Article number, 83-1023-01
Hazard: Erroneous EliA test results related to problems with liquid level detection and diluent pipetting in Phadia 250 instruments, and deformed bottles. Investigation showed problems with the liquid level detection in diluent bottle batch JJCA resulting in aspiration of no or too low volumes of liquid from the diluent bottle and from the dilution plate.
January 21, 2015Medical DevicesFDA
Phadia US Inc recalls Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since l
Hazard: During an investigation of instrument logs it was determined that In specific circumstances involving multiple steps, a rack sequencing error may occur. This will result in a mismatch between the sample ID and the test result reported for all subsequent sample racks in that run.
September 5, 2012Medical DevicesFDA
Phadia US Inc recalls PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Hazard: Customers were not following the labeled assay procedure. This was due to a letter issued to them in 2004 from Phadia GmbH, which indicated that customers could omit the pre-wash step. The omission of the pre-wash step, when combined with a change in material source in kit lot #0067, caused elevated results.