Portage, MI, United States
Phadia US Inc recalls
4 recalls recorded since 2018, most recently on 1 May 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)1
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 1 May 2023
- Reason
- 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
- Distribution
- US: CA, NJ, MI
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2041-2023, Z-2040-2023
- Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease Material Numb
- EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or pl
Terminated Class II Medical devices
- Recall started
- 14 December 2020
- Terminated
- 4 August 2022
- Reason
- 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).
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1107-2021
- EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE).
Terminated Class II Medical devices
- Recall started
- 18 December 2017
- Terminated
- 27 March 2019
- Reason
- The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.
- Distribution
- Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1312-2018, Z-1313-2018
- ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. To be used with the inst
- ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma; to be used with the in
Terminated Class II Medical devices
- Recall started
- 5 July 2017
- Terminated
- 4 October 2018
- Reason
- The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0387-2018
- Phadia 1000 Instrument, Article Number 12-3800-01.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.