Luminex Corporation 2022-05-25 Health serious FDA
Health · FDA · Recall #FDA-Z-1092-2022
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system Recall
Issued May 25, 2022 · Luminex Corporation
In May 2022, Luminex Corporation recalled the Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
What you should do
- 1 Stop using Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Luminex Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Luminex Corporation
- Category
- Health
- Recall date
- May 25, 2022
- Units affected
- Not reported
- Sold at
- US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None
- Recall number
- FDA-Z-1092-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Luminex Corporation has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.