Luminex Corporation: 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 s

Is my product affected?

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 Verigene Test Cartridge for

• UPC 00857573006010

Check against the official notice below — it lists the full affected range.

What happened

Luminex Corporation is recalling 2,838 Verigene Processor SP units (Model Numbers 10-0000-07 and 10-0000-07R) used with the Verigene Gram-Positive Blood Culture Nucleic Acid Test. The recall was initiated because three separate test fixtures used by field service engineers to calibrate and verify these devices were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. The affected devices have been distributed worldwide, including throughout the United States and in Kuwait, Austria, the United Kingdom, Spain, France, Chile, Japan, the Netherlands, Greece, Italy, Thailand, Germany, and Turkey.

The recall notice specifies numerous affected serial numbers and lot codes but does not provide a remedy or instructions for consumers on what action they should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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 VERIGENESP devices.

Details from the source

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 VERIGENESP devices. Distribution: Worldwide distribution. US nationwide and Kuwait, Austria, United Kingdom, Spain, France, Chile, Japan, Netherlands, Greece, Italy, Thailand, Germany, Turkey Quantity: 2838 units Lot/code info: 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, 9121022, 9121021, 9121019, 9121018, 9121017, 9121015, 911, 9100014, 9100012, 9100011, 9100009, 9098006, 9098005, 9098003, 9098002, 9098001, 907, 902, 10035017R, 10014012 Correct, 10014012, D09336158, 9336158, D09336157, 9336157, D09135024, 9135024, D0912, 912, D0909, 909, D908, D0908, 908, 18255014, 18150007, 18120010, 18120003, 17333003, 17250008, 17250005, 17250002, 17130060, 17017006, 16334077, 13154206, 13154205, 13154204, 13154203, 13154202, 13008020, 12333423, 12324418, 12324417, 12324416, 123244

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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