CLASS II Device recall · Reported 11 Jun 2025 · FDA Enforcement Report
Verigene Gram Negative Blood Culture (Bc-gn) Nucleic Acid Test recalled
Luminex is recalling Verigene Gram Negative Blood Culture (Bc-gn) Nucleic Acid Test, distributed nationwide in the US. The recall was initiated on 16 Apr 2025 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-1903-2025
- FDA event ID
- 96701
- Recalling firm
- Luminex, Northbrook, IL
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 16 Apr 2025
- FDA classified
- 3 Jun 2025
- Reported
- 11 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 16 Apr 2025 | Recall initiated by company | |
| 3 Jun 2025 | Classified by FDA | +48 days |
| 11 Jun 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.
Product as listed by the FDA
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test
Where it was distributed
US Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD.
Nationwide AlabamaArizonaCaliforniaConnecticutGeorgiaMarylandMinnesotaNew JerseySouth CarolinaTexasVirginiaVermontWashington
Questions about this recall
Why was it recalled?
It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.
Which lots are affected?
UDI/DI 00840487101599, Lot Number 022525021A, exp. 08/26/2025
Where was it sold?
US Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD.
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.
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