Z-1685-2017Class II

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

Name: Z-1685-2017 Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to...
Creator: Focus Diagnostics Inc
Published: 2017-02-15
License: https://open.fda.gov/license/

DiaSorin Molecular LLC / initiated 2017-02-15 / Terminated

FDA source

Focus Diagnostics Inc began a recall of Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila on 2017-02-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1685-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-15
Posted: 2017-03-27
Terminated: 2017-04-13
Recalling firm: DiaSorin Molecular LLC
Product: Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
Product code: LHL Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
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.
FDA root cause: No Marketing Application
Action: 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 The product is being withdrawn from the market.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.
Quantity in commerce: 196 units
Distribution: Product was distributed to three testing laboratories in California, New Jersey and Virginia
Product codes and lots: Unique Device Identifier IF0950: 20816101020045, lot numbers 30244, 30928, 31288, 31642, 32331, 32562, 32850

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1685-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1685-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-05	2017-03-27
Z-1686-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-05	2017-03-27

Product code LHL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)