CLASS II ONGOING Device recall · Reported 25 May 2022 · FDA Enforcement Report
Verigene Nucleic Acid Test Kit-Bc-gn Extraction Tray recalled by Luminex
Luminex is recalling Verigene Nucleic Acid Test Kit-Bc-gn Extraction Tray. The recall was initiated on 15 Feb 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-1109-2022
- FDA event ID
- 90129
- Recalling firm
- Luminex, Northbrook, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Feb 2022
- FDA classified
- 17 May 2022
- Reported
- 25 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 15 Feb 2022 | Recall initiated by company | |
| 17 May 2022 | Classified by FDA | +91 days |
| 25 May 2022 | 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
Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
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
VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Where it was distributed
US
Questions about this recall
Is Verigene Nucleic Acid Test Kit-Bc-gn Extraction Tray recalled?
Yes. Luminex recalled Verigene Nucleic Acid Test Kit-Bc-gn Extraction Tray on 15 Feb 2022. The recall is Class II and its status is Ongoing. Recall number Z-1109-2022.
Why was it recalled?
Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
Which lots are affected?
Lot Number 101321021B
Where was it sold?
US
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 21 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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