Verigene Processor SP Recalled for No Call Results
Luminex Corporation is recalling 4 Verigene Processor SP diagnostic devices that repeatedly failed to produce results, returning No Call outputs instead. Two of three customer complaints involved this malfunction.
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: This Class II device failure involves a diagnostic system that repeatedly fails to produce results. Although no illnesses or injuries have been reported, a diagnostic device that does not function constitutes a risk-of-harm product, as users rely on diagnostic output for clinical decision-making.
Plain-English summary
Luminex Corporation is recalling 4 units of the Verigene Processor SP, a medical device with Model Numbers 10-0000-07 and 10-0000-07-R. The recall includes devices with specific serial numbers: 13042054, 16347082, 17215010 (Model 10-0000-07) and 18079010 (Model 10-0000-07-R).
The devices are being recalled because customers have reported repeated failures in device operation. Two of three customer complaints were initiated due to the processors repeatedly returning No Call results instead of producing proper diagnostic output, indicating the devices are not functioning as intended.
The affected units were distributed in Texas, Connecticut, and Louisiana.
The recalled product
- Product
- Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
- Manufacturer
- Luminex Corporation
- Category
- Medical Device
- Affected units
- 4
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 (6)
- Model Number 10-0000-07
- Serial Numbers: 13042054
- 16347082
- 17215010
- Model Number 10-0000-07-R
- Serial Numbers: 18079010
Distribution
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