CLASS II ONGOING Device recall · Reported 13 Jul 2022 · FDA Enforcement Report
Verigene Enteric Pathogens Nucleic Acid Test recalled by Luminex
Luminex is recalling Verigene Enteric Pathogens Nucleic Acid Test, distributed nationwide in the US. The recall was initiated on 17 Jun 2022 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-1335-2022
- FDA event ID
- 90122
- Recalling firm
- Luminex, Northbrook, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Jun 2022
- FDA classified
- 6 Jul 2022
- Reported
- 13 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 17 Jun 2022 | Recall initiated by company | |
| 6 Jul 2022 | Classified by FDA | +19 days |
| 13 Jul 2022 | 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
There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.
Product as listed by the FDA
VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.
Questions about this recall
Why was it recalled?
There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.
Which lots are affected?
UDI 00840487101568 Luminex Lot Number 030121023A, FLOQSwab Lot Number: 2100856; Luminex Lot Number 030221023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 030221023E, FLOQSwab Lot Number: 2100856; Luminex Lot Number 030221023F, FLOQSwab Lot Number: 2100856; Luminex Lot Number 030821023A, FLOQSwab Lot Number: 2100856; Luminex Lot Number 030921023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 031021023E, FLOQSwab Lot Number: 2100856; Luminex Lot Number 031621023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 031721023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 032221023A, FLOQSwab Lot Number: 2032870; Luminex Lot Number 032421023E, FLOQSwab Lot Number: 2032870; Luminex Lot Number 032521023E, FLOQSwab Lot Number: 2100856; Luminex Lot Number 033021023E, FLOQSwab Lot Number: 2100856; Luminex Lot Number 041421023F, FLOQSwab Lot Number: 2100856; Luminex Lot Number 050521023H, FLOQSwab Lot Number: 2100856; Luminex Lot Number 050621023C, FLOQSwab Lot Number: 2032870; Luminex Lot Number 051221023E, FLOQSwab Lot Number: 2100856; Luminex Lot Number 051221023F, FLOQSwab Lot Number: 2100856, 2032870; Luminex Lot Number 051721023B, FLOQSwab Lot Number: 2100856, 2032870; Luminex Lot Number 052721023D, FLOQSwab Lot Number: 2107946; Luminex Lot Number 060121023A, FLOQSwab Lot Number: 2107946; Luminex Lot Number 060921023C, FLOQSwab Lot Number: 2032870; Luminex Lot Number 062321023E, FLOQSwab Lot Number: 2107946; Luminex Lot Number 062921023D, FLOQSwab Lot Number: 2107946; Luminex Lot Number 063021023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 063021023E, FLOQSwab Lot Number: 2107946; Luminex Lot Number 070121023D, FLOQSwab Lot Number: 2107946; Luminex Lot Number 070621023A, FLOQSwab Lot Number: 2107946; Luminex Lot Number 070821023G, FLOQSwab Lot Number: 2107946; Luminex Lot Number 070821023H, FLOQSwab Lot Number: 2107946; Luminex Lot Number 080321023C, FLOQSwab Lot Number: 2107946; Luminex Lot Number 081621023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 081721023F, FLOQSwab Lot Number: 2107946, 2110850; Luminex Lot Number 081721023G, FLOQSwab Lot Number: 2110850; Luminex Lot Number 081921023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 082021023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 082021023E, FLOQSwab Lot Number: 2110850; Luminex Lot Number 082521023D, FLOQSwab Lot Number: 2100856, 2110850; Luminex Lot Number 082621023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 083121023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 090821023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 091521023D, FLOQSwab Lot Number: 2032870; Luminex Lot Number 091621023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 091621023G, FLOQSwab Lot Number: 2110850; Luminex Lot Number 092721023A, FLOQSwab Lot Number: 2110850; Luminex Lot Number 092821023E, FLOQSwab Lot Number: 2110850; Luminex Lot Number 092921023E, FLOQSwab Lot Number: 2110850; Luminex Lot Number 100621023C, FLOQSwab Lot Number: 2110850; Luminex Lot Number 101221023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 101321023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 101921023G, FLOQSwab Lot Number: 2110850; Luminex Lot Number 102021023E, FLOQSwab Lot Number: 2107946, 2110850; Luminex Lot Number 102221023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 102821023F, FLOQSwab Lot Number: 2107946.
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.
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 90122| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Verigene CDF Nucleic Acid Test 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 | Verigene Clostridium difficile Nucleic Acid Test recalled by Luminex | Luminex | Other Bacterial Contamination | Nationwide |
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