Phadia 1000 Immunodiagnostic Instruments Recalled for Liquid Sensor Error
Phadia Ab is recalling 387 Phadia 1000 immunodiagnostic instruments due to a liquid sensor error. The recall affects facilities in 27 US states.
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 source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Phadia Ab is recalling 387 units of the Phadia 1000 Model # 12-3800-01, an automated instrument used for immunodiagnostic testing. The recall is due to a liquid sensor error identified in the device. The instruments are designed to handle all steps from sample and reagent handling to the processing of results.
The affected devices were distributed nationwide in the United States, specifically in the states of California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, and Washington. The recall includes all serial numbers associated with the Unique Device Identifier (UDI) 07333066001005.
Users of these instruments should contact Phadia Ab for further instructions regarding the recall and potential replacement or repair of the affected devices.
The recalled product
- Product
- Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results.
- Manufacturer
- Phadia Ab
- Hazard
- Affected units
- 387
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 (2)
- All Serial Numbers
- Unique Device Identifier (UDI): 07333066001005
Distribution
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