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Helix Elite Molecular Standards: Inactivated StandardRecalls & reported problems across all models

Microbiologics Inc. · 8 models in the FDA device registry

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 open recalls name at least one Helix Elite Molecular Standards: Inactivated Standard model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls
8

We found 8 models of Helix Elite Molecular Standards: Inactivated Standard by Microbiologics Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

8 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Helix Elite Molecular Standards: Inactivated Standard recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. Feb 20, 2025Class IIOpen, Classified

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

    Z-1371-2025 · Root cause: Process control · Recall details · FDA record ↗

  2. Feb 20, 2025Class IIOpen, Classified

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

    Z-1454-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

  3. Jul 27, 2022Class IIITerminated

    Product not registered for use in the UK

    Z-1740-2022 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

  4. Mar 24, 2022Class IITerminated

    QC process was not adequate for the specification range.

    Z-0954-2022 · Root cause: Process control · Recall details · FDA record ↗

  5. Mar 22, 2022Class IITerminated

    The QC process was not adequate for the specification range.

    Z-0955-2022 · Root cause: Process control · Recall details · FDA record ↗

  6. Jun 6, 2017Class IITerminated

    Real-time shelf life testing failed at 24 months

    Z-0701-2022 · Root cause: Process design · Recall details · FDA record ↗

  7. Jun 6, 2017Class IITerminated

    Real-time shelf life testing failed at 24 months

    Z-0700-2022 · Root cause: Process design · Recall details · FDA record ↗

  8. Jun 6, 2017Class IITerminated

    Real-time shelf life testing failed at 24 months

    Z-0699-2022 · Root cause: Process design · Recall details · FDA record ↗

Helix Elite Molecular Standards: Inactivated Standard models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

Other Microbiologics Inc. products

All Microbiologics Inc. devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page