Focus Diagnostics Inc: Medical Device Recall in 2017 - (Recall #: Z-1685-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 15, 2017

Date Posted: April 5, 2017

Recall Number: Z-1685-2017

Event ID: 76619

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.

Status: Terminated

Product Quantity: 196 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated