Phadia EliA RF IgM Well Recalled for Potential Low Assay Results
Phadia Ab is recalling EliA RF IgM Well kits due to a potential for reporting low assay results, which may affect rheumatoid arthritis diagnosis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a potential for inaccurate test results (low assay results) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Phadia Ab is recalling 30 kits of EliA RF IgM Well, REF 14-5600-01, due to a potential for reporting low assay results. The product is an in vitro diagnostic test intended for the quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma to aid in the diagnosis of rheumatoid arthritis.
The recall is classified as Class II by the U.S. Food and Drug Administration. The affected product is distributed in the states of New Jersey, New York, Michigan, West Virginia, and Texas, as well as Puerto Rico. The specific lot number is 0085, with an expiration date of June 30, 2020.
Healthcare providers and laboratories using this product should stop using the affected kits and contact Phadia Ab for further instructions. This recall is precautionary to ensure accurate diagnostic results for patients being evaluated for rheumatoid arthritis.
The recalled product
- Product
- EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction…
- Manufacturer
- Phadia Ab
- Hazard
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI (01) 07333066010854 (17) 200630 (10) 0085 Lot Number - 0085
Distribution
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