Microbiologics Inc: Medical Device Recall in 2022 - (Recall #: Z-1740-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N

Product Classification:

Class III

Date Initiated: July 27, 2022

Date Posted: September 21, 2022

Recall Number: Z-1740-2022

Event ID: 90761

Reason for Recall:

Product not registered for use in the UK

Status: Terminated

Product Quantity: 2

Code Information:

a. UDI Number: 10845357043846, Lot Number: HE0071-01-1, Expiration Date: 12/31/2022. b. UDI Number: 10845357043945, Lot Number: HE0073-02-2, Expiration Date: 02/28/2023.

Distribution Pattern:

International distribution to the country of United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated