Microbiologics Inc: Device Recall

Recall #Z-1371-2025 · 02/20/2025

Class II: Risk

Recall Details

Recall Number: Z-1371-2025
Classification: Class II
Product Type: Device
Recalling Firm: Microbiologics Inc
Status: Ongoing
Date Initiated: 02/20/2025
Location: Saint Cloud, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6 units

Reason for Recall

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

Product Description

Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N

Distribution Pattern

US Nationwide distribution in the states of TX. UK.

Other Recalls by Microbiologics Inc

Class II: Risk 12/02/2025

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Class II: Risk 12/02/2025

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Class II: Risk 12/02/2025

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Class II: Risk 11/13/2025

Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
Class II: Risk 06/27/2025

KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.

View all recalls by Microbiologics Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.