Microbiologics Inc: Medical Device Recall in 2025 - (Recall #: Z-1454-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N

Product Classification:

Class II

Date Initiated: February 20, 2025

Date Posted: April 2, 2025

Recall Number: Z-1454-2025

Event ID: 96381

Reason for Recall:

The RSV target may give a late Ct value and could potentially not pass QC.

Status: Ongoing

Product Quantity: 28 units

Code Information:

UDI-DI: 10845357042184; Lot Number: HE0044-131

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of KY, MT, NJ, NY, WI and the countries of Ireland, Germany, UK.

Voluntary or Mandated:

Voluntary: Firm initiated