CLASS II ONGOING Device recall · Reported 14 Oct 2020 · FDA Enforcement Report
Verigene Processor SP recalled by Luminex
Luminex is recalling Verigene Processor SP, distributed in Missouri. The recall was initiated on 10 Dec 2018 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-0054-2021
- FDA event ID
- 86358
- Recalling firm
- Luminex, Austin, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Dec 2018
- FDA classified
- 5 Oct 2020
- Reported
- 14 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 10 Dec 2018 | Recall initiated by company | |
| 5 Oct 2020 | Classified by FDA | +665 days |
| 14 Oct 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
No results/incorrect results due to failure of the hybridization heater.
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 Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
Where it was distributed
US distribution in MO. No OUS
Questions about this recall
Is Verigene Processor SP recalled?
Yes. Luminex recalled Verigene Processor SP on 10 Dec 2018. The recall is Class II and its status is Ongoing. Recall number Z-0054-2021.
Why was it recalled?
No results/incorrect results due to failure of the hybridization heater.
Which lots are affected?
Catalogue Number: 10-0000-07 Serial No. 14230205 UDI Code: 00857573006010
Where was it sold?
US distribution in MO. No OUS
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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