QC Sets and Panels: Helix Elite™ 8234Recalls & reported problems
Microbiologics Inc. · QC Sets and Panels: Helix Elite™ Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet) · Class 1
All models of QC Sets and Panels: Helix Elite (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records name this device's 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Jan 20, 2025Class IIOpen, 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 ↗
- Jan 20, 2025Class IIOpen, 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 ↗
Other Multi-analyte controls unassayed devices
- VIDAS® Quality Control 30706Biomerieux SA · Multi-analyte controls unassayed2 recalls0 reports
- Helix Elite™ Molecular Standards: Inactivated Standard HE0044NMicrobiologics Inc. · Multi-analyte controls unassayed2 recalls0 reports
- QC Sets and Panels: KWIK-STIK™ 8164Microbiologics Inc. · Multi-analyte controls unassayed2 recalls0 reports
- Multichem ID-B SR103BTechno-Path Manufacturing Limited · Multi-Analyte Controls Unassayed2 recalls0 reports
- SEROLOGY I POSITIVE CONTROL (SEROLOGY I CONTROL +) SR10352Randox Laboratories Limited · Multi-Analyte Controls Unassayed1 recall0 reports
- Helix Elite™ Molecular Standards: Inactivated Standard HE0041NMicrobiologics Inc. · Multi-analyte controls unassayed1 recall0 reports
- Multichem S Plus 08P88-10Techno-Path Manufacturing Limited · Multi-Analyte Controls Unassayed1 recall0 reports
- Helix Elite™ Molecular Standards: Inactivated Standard HE0071NMicrobiologics Inc. · Multi-Analyte Controls Unassayed1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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