Z-0477-2021Class II

Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE...

Name: Z-0477-2021 Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE...
Creator: Luminex Corporation
Published: 2020-10-13
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2020-10-13 / Terminated / root cause: manufacturing process

FDA source

Luminex Corporation began a recall of 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 -... on 2020-10-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0477-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-13
Posted: 2020-11-20
Terminated: 2024-01-22
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.
Product code: PEN Gram-Negative Bacteria And Associated Resistance Markers
Reason for recall: 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 tag: manufacturing process
FDA 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) [email protected]"
Quantity in commerce: 2838 units
Distribution: Worldwide distribution. US nationwide and Kuwait, Austria, United Kingdom, Spain, France, Chile, Japan, Netherlands, Greece, Italy, Thailand, Germany, Turkey
Product codes and lots: 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, 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0477-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0476-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-02	2020-11-20
Z-0477-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-02	2020-11-20

Product code PEN

K143653Class IIVerigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)Nanosphere, Inc. / cleared 2015-09-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)