Microbiologics Inc: Medical Device Recall in 2025 - (Recall #: Z-1371-2025)

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 SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N

Product Classification:

Class II

Date Initiated: February 20, 2025

Date Posted: March 26, 2025

Recall Number: Z-1371-2025

Event ID: 96382

Reason for Recall:

The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.

Status: Ongoing

Product Quantity: 6 units

Code Information:

UDI-DI: 10845357043563; Lot Number: HE0065-29

Distribution Pattern:

US Nationwide distribution in the states of TX. UK.

Voluntary or Mandated:

Voluntary: Firm initiated