FDA Enforcement
Class II
Ongoing
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 Number 12410002
Recall: Z-2041-2023
·
Reported July 5, 2023
Enforcement
- Recall Number
- Z-2041-2023
- 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
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 Number 12410002
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: 07333066020938 All Serial Numbers
Distribution
US: CA, NJ, MI
Quantity
9 units