Luminex Recalls Verigene Processor SP Due to Unapproved Test Fixtures
Luminex is recalling 2,838 Verigene Processor SP units because field service engineers used unapproved test fixtures to calibrate the devices.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any illnesses, injuries, or deaths, and the hazard involves unvalidated calibration fixtures rather than a direct, reported physical defect causing harm, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Luminex Corporation is recalling 2,838 units of the Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. These devices are used with the VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD. The recall covers units distributed worldwide, including the United States, Kuwait, Austria, the United Kingdom, Spain, France, Chile, Japan, the Netherlands, Greece, Italy, Thailand, Germany, and Turkey.
The recall was initiated because Luminex determined that three separate test fixtures used by field service engineers to service the processors were procured from unapproved sources. In some cases, these fixtures were manufactured using unvalidated processes. The fixtures were used to calibrate and verify the VERIGENE SP devices.
Healthcare facilities and laboratories that possess these specific model numbers should contact Luminex Corporation for instructions on how to proceed with the recall. The source text does not specify any reported illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigen
- Manufacturer
- Luminex Corporation
- Affected units
- 2,838
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)
- UDI 00857573006010 Model Number 10-0000-07
- Serial Numbers: 10110051
- 10110050
- 10110048
- 10110047
- 10099033
- 10099032
- 10099029
- 10043027
- 10043025
- 10043024
- 10043023
- 10035106
- 10035105
- 10014003
- 10014001
- 9350165
- 9350164
- 9350163
- 9350161
Distribution
Distributed nationwide across the United States.
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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