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QC Sets and Panels: Helix EliteRecalls & reported problems across all models

Microbiologics Inc. · 7 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

4 open recalls name at least one QC Sets and Panels: Helix Elite 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 7 models of QC Sets and Panels: Helix Elite 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, 4 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

QC Sets and Panels: Helix Elite 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. Jan 20, 2025Open, Classified

    Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.

    Z-1164-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  2. Jan 20, 2025Open, Classified

    Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.

    Z-1163-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  3. Jan 8, 2024Open, Classified

    The negative control was contaminated with one of the positive control pathogens (Norovirus). This would result in users getting a positive call for Norovirus when running the negative control.

    Z-1075-2024 · Root cause: Process control · Recall details · FDA record ↗

  4. Mar 3, 2022Terminated

    Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.

    Z-0844-2022 · Root cause: Incorrect or no expiration date · Recall details · FDA record ↗

  5. Feb 25, 2022Terminated

    Distributed product did not undergo proper release testing.

    Z-0784-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

  6. May 16, 2019Open, Classified

    Product is labeled with expiration date of 2021-10-31, should be 2021-03-31.

    Z-1838-2019 · Root cause: Error in labeling · Recall details · FDA record ↗

  7. Jun 6, 2017Terminated

    Real-time shelf life testing failed at 24 months

    Z-0698-2022 · Root cause: Process design · Recall details · FDA record ↗

  8. Jun 6, 2017Terminated

    Real-time shelf life testing failed at 24 months

    Z-0697-2022 · Root cause: Process design · Recall details · FDA record ↗

QC Sets and Panels: Helix Elite models

7 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