Primus Ultra2 Resolution Variants System Recalled for Lack of FDA Clearance
Primus Corporation is recalling 97 Ultra2 Resolution Variants Systems because the devices did not receive FDA pre-market approval or clearance.
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 is regulatory (lack of clearance) rather than a direct physical defect causing injury, and no illnesses or injuries are reported in the source text.
Plain-English summary
Primus Corporation is recalling 97 units of the Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation. The recall includes the analyzer units and associated reagents and columns. The devices were distributed in 20 U.S. states and 9 countries.
The recall was initiated because the product did not receive pre-market approval or clearance from the U.S. Food and Drug Administration. This means the devices were not authorized for marketing in the United States.
Healthcare facilities and laboratories that possess these devices should stop using them and contact Primus Corporation for instructions on return or disposal. Consumers should not use these devices for diagnostic purposes.
The recalled product
- Product
- Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
- Manufacturer
- Primus Corporation
- Affected units
- 97
Distribution
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