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

FDA device recall Z-1685-2017 · posted 2017-03-27 · Terminated

Recall details

Recalling firm

Focus Diagnostics Inc

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.

Action taken

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 The product is being withdrawn from the market.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.

Root cause

No Marketing Application

Status

Terminated

Product code

LHL

Quantity affected

196 units

Distribution

Product was distributed to three testing laboratories in California, New Jersey and Virginia

Date initiated

2017-02-15

Date posted

2017-03-27

Date terminated

2017-04-13

Location

Cypress, CA