Moderate FDA (Devices)·Z-0476-2021·Announced 2020-12-02

Luminex Recalls Verigene Processor SP Due to Unapproved Service Fixtures

Luminex is recalling 2,838 Verigene Processor SP units because field service engineers used unapproved test fixtures to calibrate and verify 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 hazard involves the use of unapproved and unvalidated test fixtures for calibration, which is a quality control issue. No specific injuries, illnesses, or deaths are reported in the source text, and the defect is related to service equipment rather than a direct structural failure or contamination of the device itself.

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-Positive Blood Culture Nucleic Acid Test, BC-GP, 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 the affected Verigene Processor SP units should contact Luminex Corporation for instructions on how to proceed with the recall. Specific serial numbers for the affected units are listed in the official FDA recall record Z-0476-2021.

The recalled product

Product: Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigen
Manufacturer: Luminex Corporation
Category: Medical Device — In Vitro Diagnostics
Hazard: calibration-error
unapproved-parts
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 →

Same manufacturer · Luminex Corporation

See all →

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Same hazard · calibration error