Luminex Verigene Processor SP Recalled for Potential False Negative Results
Luminex is recalling Verigene Processor SP systems because an instrument failure may cause false negative results for Gram-positive and Gram-negative blood culture tests.
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, and the hazard involves a diagnostic device failure that could lead to missed diagnoses (false negatives) in blood cultures, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Luminex Corporation is recalling the Verigene Processor SP, including refurbished units, in conjunction with the VERIGENE Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) and Gram Negative (BC-GN) assays. The recall involves 3,016 systems distributed worldwide, including across the United States and numerous international markets.
The recall is being issued due to an instrument failure mode that may result in a false negative call for either the BC-GP or BC-GN tests. A false negative result in blood culture testing could lead to a missed diagnosis of infection, potentially delaying appropriate clinical treatment.
Healthcare facilities and laboratories that have purchased or received these Verigene Processor SP systems should contact Luminex Corporation for instructions on how to proceed with the recall. The specific serial numbers affected are listed in the official FDA recall notice Z-2775-2020.
The recalled product
- Product
- Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
- Manufacturer
- Luminex Corporation
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 (20)
- Verigene Processor SP
- 10-0000-07
- GTIN 00840487101483
- Serial Numbers: 902
- 907
- 908
- 909
- 911
- 912
- 9098001
- 9098002
- 9098003
- 9098005
- 9098006
- 9100009
- 9100011
- 9100012
- 9100014
- 9121015
- 9121017
Distribution
Part of a larger recall action
This product is one of 2 recalled by Luminex Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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