Focus Diagnostics Inc: Medical Device Recall in 2014 - (Recall #: Z-1144-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.

Product Classification:

Class II

Date Initiated: February 4, 2014

Date Posted: March 12, 2014

Recall Number: Z-1144-2014

Event ID: 67436

Reason for Recall:

Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to the potential of false positive Flu A, Flu B and RSV signals.

Status: Terminated

Product Quantity: 2,175 kits

Code Information:

Model Number MOL2650. Lot Numbers: 24493, 24495, 24535, 24536, 24591, 24603, 24605, 24732, 24773, 24788, 24797, 24807.

Distribution Pattern:

Worldwide Distribution: US (nationwide) and to countries of:Canada, Sweden, Belgium, Spain, Portugal, Slovenia, and Israel.

Voluntary or Mandated:

Voluntary: Firm initiated