FDA Enforcement
Class II
Ongoing
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 plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease Material Number 14553901
Recall: Z-2040-2023
·
Reported July 5, 2023
Enforcement
- Recall Number
- Z-2040-2023
- Event ID
- 92365
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Phadia US Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 5, 2023
- Initiation Date
- May 1, 2023
- Classification Date
- June 29, 2023
- Address
- 4169 Commercial Ave, N/A, Portage, MI, 49002-9701, United States
Description
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 plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease Material Number 14553901
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
Code Info
UDI: 07333066010847 All lots
Distribution
US: CA, NJ, MI
Quantity
568 units US