CLASS II ONGOING Device recall · Reported 5 Jul 2023 · FDA Enforcement Report
Verigene Clostridium difficile Nucleic Acid Test recalled by Luminex
Luminex is recalling Verigene Clostridium difficile Nucleic Acid Test, distributed nationwide in the US. The recall was initiated on 5 Jun 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2024-2023
- FDA event ID
- 92451
- Recalling firm
- Luminex, Northbrook, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Jun 2023
- FDA classified
- 28 Jun 2023
- Reported
- 5 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Bacterial Contamination
- Device type
- Other Medical Devices
Timeline
| 5 Jun 2023 | Recall initiated by company | |
| 28 Jun 2023 | Classified by FDA | +23 days |
| 5 Jul 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.
Product as listed by the FDA
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
Where it was distributed
Worldwide and US Nationwide Distribution
Questions about this recall
Why was it recalled?
It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.
Which lots are affected?
UDI/DI , Lot Numbers: 071222022D, 100622022D
Where was it sold?
Worldwide and US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 92451| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Verigene Enteric Pathogens Nucleic Acid Test (EP) recalled by Luminex | Luminex | Other | Nationwide |
More recalls from Luminex
All 39| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Verigene Gram Negative Blood Culture (Bc-gn) Nucleic Acid Test recalled | Luminex | Other | Nationwide |
| Device | CLASS II | Verigene Gram Positive Blood Culture (Bc-gp) Nucleic Acid Test recalled | Luminex | Other Bacterial Contamination | Nationwide |
| Device | CLASS II | Verigene Bc-gp Utility Tray Carrier) recalled by Luminex | Luminex | Device Malfunction | Nationwide |
| Device | CLASS II | Verigene Enteric Pathogens Nucleic Acid Test (EP) recalled by Luminex | Luminex | Other | Nationwide |
| Device | CLASS II | Aries Sars-CoV-2 Assay recalled by Luminex | Luminex | Potency & Assay | Nationwide |
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