QC Sets and Panels: Helix Elite™ 8200 Cepheid Xpert® C. difficile/Epi Control PanelRecalls & reported problems
Microbiologics Inc. · Cepheid Xpert® C. difficile/Epi Control Panel · Class 2
All models of QC Sets and Panels: Helix Elite (7)
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
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record 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
- May 16, 2019Class IIIOpen, 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 ↗
Other Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays devices
- QC Sets and Panels: Helix Elite™ 8193 BD MAX™ CT/GC/TV 20-Day QC PanelMicrobiologics Inc. · Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays1 recall0 reports
- QC Sets and Panels: Helix Elite™ 8199 Cepheid Xpert® Respiratory Control PanelMicrobiologics Inc. · Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays1 recall0 reports
- Aptima® KIT, BOX 1, REFRIGERATED, ABV, 100T, IVDHologic, Inc. · Assayed external control material for microbiology nucleic acid amplification (NAT) assays1 report
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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