Helix Elite™ Molecular Standards: Inactivated Standard HE0044NRecalls & reported problems
Microbiologics Inc. · Helix Elite™ Molecular Standards Inactivated Influenza A/B and Respiratory Syncytial Virus · Class 1
All models of Helix Elite Molecular Standards: Inactivated Standard (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names 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, 1 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
- 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 ↗
- Jun 6, 2017Class IITerminated
Real-time shelf life testing failed at 24 months
Z-0701-2022 · Root cause: Process design · Recall details · FDA record ↗
Other Multi-analyte controls unassayed devices
- QC Sets and Panels: Helix Elite™ 8234Microbiologics Inc. · Multi-analyte controls unassayed2 recalls0 reports
- VIDAS® Quality Control 30706Biomerieux SA · 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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