Phadia Prime software recall for EliA assay retesting function
Phadia Ab is recalling Phadia Prime software versions up to 2.1.4 to prevent the use of the 'OK to All' function when rejecting and retesting EliA assay samples.
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, but the source text does not report any hospitalizations, significant injuries, or illnesses. The hazard is a software function restriction to prevent potential errors, fitting the criteria for a moderate severity recall without reported harm.
Plain-English summary
Phadia Ab is recalling Phadia Prime software, article number 12-4101-00, used in combination with the Phadia 250 Instrument and EliA Assays. The recall covers all software versions up to and including 2.1.4. A total of 2,307 units were distributed to the United States, specifically to the states of Texas, Virginia, New Jersey, Massachusetts, Indiana, Georgia, Utah, Tennessee, California, Mississippi, North Carolina, Maine, and Oregon.
The recall is issued to inform operators not to use the 'OK to All' function when rejecting and retesting samples with any EliA assay. The 'OK' function may still be used for rejecting single tests and dilution of samples in accordance with the product's Description of Use (DfU). The source text does not report any specific illnesses, injuries, or adverse health consequences associated with this software defect.
Operators of the Phadia 250 system performing EliA Assays should stop using the 'OK to All' function for the specified retesting procedures immediately. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.
- Manufacturer
- Phadia Ab
- Affected units
- 2,307
Distribution
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