Recall archive / FDA device enforcement
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system — FDA record Z-1092-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 5, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
- Reason
- Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
- Classification
- Class II
- Recalling firm
- Luminex Corporation
- Quantity
- 24 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1092-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- May 25, 2022
- Recall initiation date
- Apr 5, 2022
- Center classification date
- May 13, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.