Recall record at a glance
| Official record | Z-2040-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Phadia US Inc. |
| Report date | Jul 5, 2023 |
| Recall initiation date | May 1, 2023 |
| Quantity | 568 units US |
| Location | Portage, MI, United States |
Official product 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
Why the product was recalled
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 information
US: CA, NJ, MI
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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