CLASS II ONGOING Device recall · Reported 13 Dec 2023 · FDA Enforcement Report
Verigene Bc-gp Utility Tray Carrier) recalled by Luminex
Luminex is recalling Verigene Bc-gp Utility Tray Carrier), Gram-Positive Blood Culture Nucleic Acid Test, distributed nationwide in the US. The recall was initiated on 7 Nov 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-0500-2024
- FDA event ID
- 93364
- Recalling firm
- Luminex, Northbrook, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Nov 2023
- FDA classified
- 6 Dec 2023
- Reported
- 13 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 7 Nov 2023 | Recall initiated by company | |
| 6 Dec 2023 | Classified by FDA | +29 days |
| 13 Dec 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
Potentially defective utility trays in the reagent kits.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.
Where it was distributed
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GL, IL, IN, MA, MD, MI, MN, MO, MS, NE, NY, OH, OK, OR, TN, TX, UT, VA, WA, and WI. The country of Italy.
Nationwide ArizonaCaliforniaColoradoDelawareFloridaIllinoisIndianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiNebraskaNew YorkOhioOklahomaOregonTennesseeTexas
Questions about this recall
Why was it recalled?
Potentially defective utility trays in the reagent kits.
Which lots are affected?
Lot number 062123018C, Exp. 12/20/2023, UDI (01)00840487101674(17)231220(10)062123018C.
Where was it sold?
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GL, IL, IN, MA, MD, MI, MN, MO, MS, NE, NY, OH, OK, OR, TN, TX, UT, VA, WA, and WI. The country of Italy.
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.
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 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 |
| Device | CLASS II | Aries Sars-CoV-2 Assay recalled by Luminex | Luminex | Potency & Assay | Nationwide |
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