Focus Diagnostics Legionella IFA Substrate Slide Recalled for Regulatory Status
Focus Diagnostics is recalling Legionella IFA Substrate Slides because the device was found not to be 510(k) exempt.
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 a regulatory compliance issue (lack of 510(k) exemption) rather than a direct physical safety defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Focus Diagnostics Inc is recalling 1,400 units of the Legionella IFA Substrate Slide (IF0951). The product is intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
The recall was initiated after a submission for a CLIA database update from Focus Diagnostics to DiaSorin Molecular revealed that the Legionella IFA device (IF0950) is not 510(k) exempt. The affected units are identified by code IF0951 and lot numbers 29428 and 31871.
The product was distributed to three testing laboratories located in California, New Jersey, and Virginia. No specific consumer action is detailed in the source text beyond the recall notification.
The recalled product
- Product
- Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
- Manufacturer
- Focus Diagnostics Inc
- Affected units
- 1,400
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)
- IF0951: 10816101020055
- lot numbers 29428
- 31871
Distribution
Part of a larger recall action
This product is one of 2 recalled by Focus Diagnostics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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