Reported Aug 19, 2020 · Terminated
Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product…
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 · 12212 Technology Blvd · Austin, TX · 78727-6101
Is this the product you have?
- Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN
- IVD - Product Usageutilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested
- Lot codes and dates
Verigene Processor SP10-0000-07GTIN 00840487101483
- Serial Numbers
2,027 of 2,027 codes
902907908909911912909800190980029098003909800590980069100009910001191000129100014912101591210179121018912101991210219121022913502491350269135027913502891350299163034916303591630389163039916304091630419163042916304391630449163045916304692020479202050920205192020529202053920205492100559210056921005792100589210059921006192100629230063923006492300659230066923006792300689230069923007092300749230075
- Serial Numbers
749 of 749 codes
9100008910001391210169135023913503091630329163033916303692020499255076927007992700819270083927708792880989288099928810092931049293105929310792931089293110929811193131259325137932513993251409325141932514293361439336151933615293361539336154935016610014002100140041001400510014006100140071001400810014009100140101001401110035013100350141003501510035016100350171003501810035019100350201004302110043022100430261009903010099031100990351009903610099038
- Amount recalled
- Total = 3,016 systems (2240 Verigene Processor SP and 776 Verigene Processor SP Refurbished)
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
Why it was recalled
An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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