Focus Diagnostics Inc: Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.

Is my product affected?

Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.

• UPC 20816101020045

Check against the official notice below — it lists the full affected range.

What happened

Focus Diagnostics Inc. is recalling its Legionella IFA device (model IF0950), which is used to detect and measure antibodies to Legionella pneumophila in human blood serum. The company discovered that this device does not have the required 510(k) exemption status after submitting a CLIA database update to DiaSorin Molecular. A total of 196 units were distributed to testing laboratories in California, New Jersey, and Virginia, with affected lot numbers being 30244, 30928, 31288, 31642, 32331, 32562, and 32850.

The recall record does not specify what action affected consumers or laboratories should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510(k) exempt.

Details from the source

Reason for recall: After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510(k) exempt. Distribution: Product was distributed to three testing laboratories in California, New Jersey and Virginia Quantity: 196 units Lot/code info: Unique Device Identifier IF0950: 20816101020045, lot numbers 30244, 30928, 31288, 31642, 32331, 32562, 32850

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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