Luminex Corporation: 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 Verigene Test Cartridge for each sample tested.

Recall number

Z-0477-2021

Recalling firm

Luminex Corporation

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 Verigene Test Cartridge for each sample tested.

Status

Terminated

Initiated

2020-10-13

Posted

not on file

Terminated

2024-01-22

Reason

Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENE SP devices.

Root cause

Nonconforming Material/Component

Action

On 10/13/2020, the firm sent the following notice: "As part of our corrective action plan, Luminex will be updating software on all VERIGENE SP instruments in the coming weeks, and systematically visiting every VERIGENE customer site to perform a supplemental preventative maintenance on your instruments. We will also likely be sending out a series of Customer Advisory Notifications with additional information on items related to our remediation efforts surrounding the Warning Letter, as well as updates related to other items identified for improved product performance. During this time, you may continue to use your VERIGENE products as directed in the package inserts for each product, or as otherwise directed through further Luminex communications. If you have any question, please do not hesitate to contact Luminex Global Support Services using the contact details below: Luminex Global Support Services 1-877-785-2323 (U.S. and Canada) +1-512-381-4397 (Outside U.S. and Canada) support@luminexcorp.com"

Quantity

2838 units

Distribution

Worldwide distribution. US nationwide and Kuwait, Austria, United Kingdom, Spain, France, Chile, Japan, Netherlands, Greece, Italy, Thailand, Germany, Turkey

Lot, serial or model codes

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, 9350160, 9350159, 9336156, 9336150, 9336149, 9336148, 9336147, 9336146, 9336145, 9336144, 9325152, 9325151, 9325138, 9320127, 9313124, 9313123, 9313122, 9313121, 9313120, 9313119, 9298118, 9298117, 9298116, 9293111, 9293109, 9293106, 9293103, 9288102, 9288097, 9288096, 9288095, 9277094, 9277093, 9277092, 9277091, 9277090, 9277089, 9277088, 9270087, 9270086, 9270085, 9270084, 9270082, 9270080, 9255080, 9255079, 9255077, 9255072, 9255071, 9230075, 9230074, 9230070, 9230069, 9230068, 9230067, 9230066, 9230065, 9230064, 9230063, 9210062, 9210061, 9210059, 9210058, 9210057, 9210056, 9202052, 9202047, 9163046, 9163045, 9163044, 9163044, 9163043, 9163042, 9163041, 9163040, 9163039, 9163038, 9163035, 9163034, 9135029, 9135028, 9135027, 9135026, 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18250010, 18172008, 13161218, 13105149, 13105145, 12219236, 12079064, 12079061, 11276121, 11276111, 11152052, 11152051, 10250123, 10250120, 10139083, 10139081, 10139080, 10099037, 14237220, 14237218, 14237216, 15040039, 15040038, 13099133, 13099132, 13099131, 12156156, 12156155, 17234007, 14090075, 14090074, 14090073, 13161219, 11276114, 11276113, 11276112, 10250121, 15327110, 14090076, 13042052, 13024038, 11250095, 11250094, 10182100, 13210280, 13210279, 18288012, 17017002, 13024037, 13024034, 12285353, 12285352, 12285349, 12223239, 12219237, 12219235, 12086071, 11186054, 11152053, 11152045, 10250122, 10139082  Model Number 10-0000-07R, Serial Numbers:  11186058, 9298111, 18255010, 17215009, 17096033, 16277053, 16125025, 15131079, 14191153, 13178234, 20094002, 19295001, 19260003, 19233003, 19206005, 19123005, 19123002, 19095013, 19095001, 19084015, 19084013, 19084012, 19084011, 19084001, 19072009, 19072006, 19057013, 19036003, 19036002, 18344008, 18344004, 18333001, 18318015, 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510(k) numbers

["K143653"]

PMA numbers

not on file

Product code

PEN

Firm FEI

3006028115

Firm city

Northbrook

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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