Focus Diagnostics Legionella IFA Recalled for Regulatory Status Error
Focus Diagnostics is recalling Legionella IFA devices because the company discovered the product is not 510(k) exempt. The recall affects 196 units distributed to three testing laboratories.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a regulatory documentation and classification issue (lack of 510(k) exemption) rather than a product defect or safety hazard. No injuries or illnesses are reported, fitting the criteria for a low-severity documentation issue.
Plain-English summary
Focus Diagnostics Inc is recalling 196 units of the Legionella IFA (IF0950) device. This product is intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila. The recall was initiated after the company, following a submission for a CLIA database update to DiaSorin Molecular, determined that the device is not 510(k) exempt.
The affected units were distributed to three testing laboratories located in California, New Jersey, and Virginia. The specific lot numbers involved in this recall are 30244, 30928, 31288, 31642, 32331, 32562, and 32850. The Unique Device Identifier for the product is IF0950: 20816101020045.
No illnesses or injuries have been reported in connection with this recall. The issue is administrative, relating to the regulatory classification of the device rather than a manufacturing defect or safety hazard in the product itself.
The recalled product
- Product
- Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
- Manufacturer
- Focus Diagnostics Inc
- Affected units
- 196
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 (8)
- Unique Device Identifier IF0950: 20816101020045
- lot numbers 30244
- 30928
- 31288
- 31642
- 32331
- 32562
- 32850
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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