Phadia Recalls EliA SmDP Wells Due to Invalid Test Results
Phadia Ab is recalling 76 units of EliA SmDP Well lot 0018 because nonspecific signals may cause incorrect positive or equivocal test results for systemic lupus erythematosus.
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. The hazard involves incorrect diagnostic results (false positives/equivocal) rather than direct physical injury or death, fitting the criteria for a moderate severity recall involving potential misdiagnosis.
Plain-English summary
Phadia Ab is recalling 76 units of EliA SmDP Well, Article Number 14-5624-01, Lot 0018, with an expiration date of 11/30/2016. The product is an in vitro diagnostic test intended for the semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma to aid in the clinical diagnosis of systemic lupus erythematosus (SLE).
The recall was initiated because all equivocal and positive results (greater than or equal to 7 EliA U/ml) on this specific lot may be incorrect and must be considered invalid. Patient samples in complaint investigations caused unspecific signals up to 22 U/ml on EliA SmDP well lot 0018. The source text clarifies that these nonspecific signals are not caused by anti-Sm antibodies, nor by streptavidin antibodies.
The affected units were distributed in the United States in the states of North Carolina, Georgia, New Jersey, New York, Pennsylvania, Texas, Illinois, Michigan, Montana, New Mexico, and Oregon. Healthcare facilities and laboratories should stop using the affected lot and contact the manufacturer for instructions on handling the product.
The recalled product
- Product
- EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE)…
- Manufacturer
- Phadia Ab
- Affected units
- 76
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)
- Product number: 14-5624-01 Lot: 0018 Exp date: 11/30/2016
Distribution
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