Focus Diagnostics Inc: Medical Device Recall in 2015 - (Recall #: Z-0238-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.

Product Classification:

Class II

Date Initiated: October 2, 2015

Date Posted: November 18, 2015

Recall Number: Z-0238-2016

Event ID: 72395

Reason for Recall:

Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results.

Status: Terminated

Product Quantity: 38 kits

Code Information:

26341, 27011

Distribution Pattern:

Non US (worldwide): Czech Republic, Denmark, Germany, Italy, Spain and Colombia

Voluntary or Mandated:

Voluntary: Firm initiated