CLASS II ONGOING Device recall · Reported 20 Apr 2022 · FDA Enforcement Report
Verigene Processor SP recalled by Luminex
Luminex is recalling Verigene Processor SP, distributed in Connecticut, Louisiana, Texas. The recall was initiated on 22 Apr 2019 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-0920-2022
- FDA event ID
- 89051
- Recalling firm
- Luminex, Northbrook, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Apr 2019
- FDA classified
- 13 Apr 2022
- Reported
- 20 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 22 Apr 2019 | Recall initiated by company | |
| 13 Apr 2022 | Classified by FDA | +1087 days |
| 20 Apr 2022 | 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
Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
Product as listed by the FDA
Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Where it was distributed
US: TX, CT, LA
Questions about this recall
Why was it recalled?
Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
Which lots are affected?
Model Number 10-0000-07, Serial Numbers: 13042054,16347082,17215010; Model Number 10-0000-07-R, Serial Numbers: 18079010
Where was it sold?
US: TX, CT, LA
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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