Luminex VERIGENE Processor SP Recalled for Heater Failure
Luminex is recalling one VERIGENE Processor SP system in Missouri due to a hybridization heater failure that may cause incorrect test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves incorrect diagnostic results, which poses a risk of harm to patient care, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Luminex Corporation is recalling one VERIGENE Processor SP system, Model No. 10-0000-07, in the United States. The device is an in vitro diagnostic tool intended for processing and identifying nucleic acids.
The recall was initiated because a failure of the hybridization heater may result in no results or incorrect results. The specific unit affected has Catalogue Number 10-0000-07, Serial No. 14230205, and UDI Code 00857573006010.
The affected system was distributed in Missouri. No other units are reported to be affected. Users of this specific device should contact Luminex Corporation for further instructions regarding the recall.
The recalled product
- Product
- VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
- Manufacturer
- Luminex Corporation
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalogue Number: 10-0000-07 Serial No. 14230205 UDI Code: 00857573006010
Distribution
Distributed in 1 state:
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