Phadia 1000 Instrument Recalled for Rack Sequencing Error
Phadia US Inc is recalling 146 Phadia 1000 instruments due to a software error that may cause sample ID and test result mismatches.
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 involves a software error leading to data mismatch rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity recall.
Plain-English summary
Phadia US Inc is recalling 146 units of the Phadia 1000 Instrument (introduced as UniCAP 1000), Article number 12-3800-01. The recall covers all instrument software versions since the product's launch in 2003. The devices are used with multiple ImmunoCAP assays for allergen testing.
The recall was initiated after an investigation of instrument logs revealed that a rack sequencing error may occur in specific circumstances involving multiple steps. This error results in a mismatch between the sample ID and the test result reported for all subsequent sample racks in that run.
The affected units were distributed nationwide, including in Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, and Washington. Users should contact Phadia US Inc for further instructions regarding the software issue.
The recalled product
- Product
- Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software…
- Manufacturer
- Phadia US Inc
- Affected units
- 146
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)
- Part Number 12-3800-01
Distribution
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