Phadia Recalls EliA dsDNA Well Kits Due to Potential False Positive Results
Phadia US Inc is recalling EliA dsDNA Well kits because decreased positive control values may cause false positive test results for systemic lupus erythematosus.
What this means for you
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, but the source text explicitly states that no illnesses or injuries have been reported. The hazard is a potential diagnostic error (false positives) rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity score.
Plain-English summary
Phadia US Inc is voluntarily recalling 365 kits of the EliA dsDNA Well, Material Number 14-5500-01. The product is intended for the in-vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE).
The recall is due to decreased values for the EliA ANA Positive Control when using the specific lot, which may potentially cause false positive results, leading to an increase in patient test results. The affected product is identified by Carrier Lot Number BFA3Y and Kit Lot Number 0142, with UDI 07333066019406.
The affected kits were distributed nationwide in the United States. Users should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE). Material Number: 14-5500-01
- Manufacturer
- Phadia US Inc
- Affected units
- 365
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 (3)
- Carrier Lot Number: BFA3Y
- Kit Lot Number: 0142
- (UDI): 07333066019406
Distribution
Distributed nationwide across the United States.
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