The Recall Desk

FDA (Devices) recall action 86124

Luminex Corporation recalled 2 products on 2020-12-02

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-12-02
Critical
0
Units
5,676

Why these products were recalled

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.

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··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.

    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
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-12-02

    Luminex Recalls Verigene Processor SP Due to Unapproved Test Fixtures

    Luminex is recalling 2,838 Verigene Processor SP units because field service engineers used unapproved test fixtures to calibrate the devices.

    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 Verigen
    Category
    Distribution
    0 states