CLASS II ONGOING Device recall · Reported 25 May 2022 · FDA Enforcement Report
Verigene Processor SP recalled by Luminex
Luminex is recalling Verigene Processor SP, distributed in 16 states. The recall was initiated on 5 Apr 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-1092-2022
- FDA event ID
- 90023
- Recalling firm
- Luminex, Austin, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Apr 2022
- FDA classified
- 13 May 2022
- Reported
- 25 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 5 Apr 2022 | Recall initiated by company | |
| 13 May 2022 | Classified by FDA | +38 days |
| 25 May 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Where it was distributed
US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None
ArizonaCaliforniaColoradoFloridaGeorgiaIllinoisIndianaKentuckyMaineMichiganNebraskaOhioPennsylvaniaTexasVermontWashington
Questions about this recall
Why was it recalled?
Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
Which lots are affected?
Serial Numbers for 10-0000-07: 17340003 19044007 20133004 18128002 18214004 12061048 18191010 13193254 13051068 21029902 16277059 19233005 11250096 14069051 18255003 *18039010 *20212006 *19317004 *19206009 *18057008 Serial Numbers added 6.23.22 for 10-0000-07R: 18191010 13051068 14069051 *12198198 *12278344 *14322267 *12271338 Serial Numbers added 7.14.22 for 10-0000-07R: 18226007 and 16242043 Serial Numbers added 7.14.22 for 10-0000-07: 17062030, 18235008 and 19192006
Where was it sold?
US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None
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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