CLASS II ONGOING Device recall · Reported 14 Jul 2021 · FDA Enforcement Report
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) recalled
Luminex is recalling Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex), distributed nationwide in the US. The recall was initiated on 30 Oct 2020 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-2006-2021
- FDA event ID
- 88137
- Recalling firm
- Luminex, Northbrook, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Oct 2020
- FDA classified
- 2 Jul 2021
- Reported
- 14 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 30 Oct 2020 | Recall initiated by company | |
| 2 Jul 2021 | Classified by FDA | +245 days |
| 14 Jul 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for a false-negative result.
Product as listed by the FDA
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
Where it was distributed
Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.
Nationwide AlabamaArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichigan
Questions about this recall
Why was it recalled?
Potential for a false-negative result.
Which lots are affected?
030520024A, 030720024A, 031020024A, 031120024A, 031320024A, 031620024C, 031820024A, 031920024A, 032120024A, 032320024A, 032420024A, 032620024A, 033120024A, 040220024A, 040320024A, 040420024A, 040620024A, 040720024A, 040920024A, 041120024A, 041420024A, 041620024A, 041820024A, 042020024A, 042120024A, 042320024A, 042520024A, 060320024A, 061320024A, 062320024A, 070820024A, 071020024A, 072120024A, 072920024A, 080720024A, 081920024A and 091120024A
Where was it sold?
Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.
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
5 other products · FDA event 88137| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Verigene Gram Negative Blood Culture Nucleic Acid Test (Bc-gn) recalled | Luminex | Other | Nationwide | |
| CLASS II | Verigene Enteric Pathogens Nucleic Acid Test (EP) recalled by Luminex | Luminex | Other | Nationwide | |
| CLASS II | Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) recalled | Luminex | Other Bacterial Contamination | Nationwide | |
| CLASS II | Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) recalled | Luminex | Other | Nationwide | |
| CLASS II | Verigene Gram-Positive Blood Culture Nucleic Acid Test (Bc-gp) recalled | 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 |
Other CPAP & Ventilators recalls
All 554| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |