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 s

Is my product affected?

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

• UPC 00857573006010

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

What happened

Luminex Corporation is recalling 2,838 units of Verigene Processor SP devices (Model Numbers 10-0000-07 and 10-0000-07R) used with the Verigene Gram-Negative 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 obtained from unapproved sources and, in some cases, manufactured using unvalidated processes. These devices have been distributed worldwide, including throughout the United States and in multiple countries including Kuwait, Austria, the United Kingdom, France, Japan, Germany, and others.

The affected devices are identified by specific serial numbers and lot codes listed in the recall notice. According to the recall record provided, no remedy information is specified for affected consumers.

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 VERIGENE SP 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 VERIGENE SP 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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