Focus Diagnostics Inc: Medical Device Recall in 2014 - (Recall #: Z-0846-2014)

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 A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is 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.

Product Classification:

Class II

Date Initiated: January 10, 2014

Date Posted: February 5, 2014

Recall Number: Z-0846-2014

Event ID: 67213

Reason for Recall:

Focus Diagnostics is initiating an urgent safety notice correction for Simplexa Flu A/B & RSV Direct assay (MOL2650) because Focus Diagnostics has received some customer complaints of Simplexa Flu A/B & RSV lots due to sporadic false positive RSV signals, which may result in a higher RSV false positive rate.

Status: Terminated

Product Quantity: 1,052 kits

Code Information:

Model Number MOL2650 Lot Numbers: 24493, 24495, 24535, 24536.

Distribution Pattern:

Worldwide Distribution - US (Nationwide) including states of: NY, MA, NJ, OH, CA, HI, CO, MN, FL, PA, IA, WI, AZ, TX, TN, IL, SD, MO, NM, AR, WV, MI and Internationally to: Sweden, Israel, Canada, and Slovenia. .

Voluntary or Mandated:

Voluntary: Firm initiated