Focus Diagnostics Inc: Medical Device Recall in 2017 - (Recall #: Z-1686-2017)

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 Substrate Slide (IF0951) 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-1686-2017

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: 1,400 units

Code Information:

IF0951: 10816101020055, lot numbers 29428, 31871

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated