Legionella IFA (IF0950) intended for qualitatively… recallZ-1685-2017 · Focus Diagnostics Inc · initiated Feb 15, 2017

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Focus Diagnostics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: No Marketing Application

What the company is doing

Focus Diagnostics/DiaSorin Molecular is issuing a medical device correction for the Legionella IFA (Immuno Fluoresence Assay). On February 1, 2017, the firm was notified that the Legionella IFA was not properly classified according to 21 CFR Part 807. The product is being withdrawn from the market. Use of the product should be immediately discontinued, and any remaining inventory should be immediately destroyed. The firm sent notice to its consignees, which should be reviewed with the facility's laboratory or mediclal director. Patient results obtained with all lots of the affected product should be evaluated by the clinician and if recommended, retested by another method.

Recall details

Recall number: Z-1685-2017
Status: Terminated
Initiated by the company: Feb 15, 2017
Posted by the FDA: Mar 27, 2017
Recalling firm: Focus Diagnostics Inc
Quantity: 196 units
Product code: LHL
Distribution: Product was distributed to three testing laboratories in California, New Jersey and Virginia

Product description

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

Code information (models, lots, serial numbers)

Unique Device Identifier IF0950: 20816101020045, lot numbers 30244, 30928, 31288, 31642, 32331, 32562, 32850

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Legionella IFA IF0950
Diasorin Molecular LLC · Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 76619).

Z-1686-2017 · Terminated
Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

How recalls are matched to devices · Editorial policy · Report an error on this page