Reported Dec 2, 2020 · Terminated
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood…
Luminex Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Luminex Corporation · 4088 Commercial Ave · Northbrook, IL · 60062-1829
Is this the product you have?
- 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 UsageIVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested
- Lot codes and dates
- UDI 00857573006010 Model Number 10-0000-07
- Serial Numbers
369 of 369 codes
101100511011005010110048101100471009903310099032100990291004302710043025100430241004302310035106100351051001400310014001935016593501649350163935016193501609350159933615693361509336149933614893361479336146933614593361449325152932515193251389320127931312493131239313122931312193131209313119929811892981179298116929311192931099293106929310392881029288097928809692880959277094927709392770929277091927709092770899277088927008792700869270085
- Serial Numbers
769 of 769 codes
11186058929811118255010172150091709603316277053161250251513107914191153131782342009400219295001192600031923300319206005191230051912300219095013190950011908401519084013190840121908401119084001190720091907200619057013190360031903600218344008183440041833300118318015183180091829901218299008182990071829900318288008182640081826400718264006182640021825501518255008182550061825001318250008182350091823500718235005182260131822601218226011182260071822600118214007182050061819101218177012
- Amount recalled
- 2838 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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 VERIGENE SP devices.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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