The Recall Desk

FDA (Devices) recall action 69034

Nanosphere, Inc. recalled 5 products on 2014-10-01

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2014-10-01
Critical
0
Units
5,920

Why these products were recalled

Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.

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.

States named across these recalls

1–5 of 5

  • ModerateFDA (Devices)··2014-10-01

    Nanosphere Recalls Verigene Gram-Positive Blood Culture Test Due to Processing Errors

    Nanosphere is recalling 4,440 units of the Verigene Gram-Positive Blood Culture Nucleic Acid Test because Tip Holder Assemblies caused increased processing errors.

    Product
    The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which…
    Category
    Distribution
    25 states
  • ModerateFDA (Devices)··2014-10-01

    Nanosphere Recalls Verigene Clostridium difficile Test Due to Processing Errors

    Nanosphere is recalling 80 units of the Verigene Clostridium difficile Nucleic Acid Test due to increased processing errors caused by Tip Holder Assemblies.

    Product
    The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic strains Clostridium difficile and for presumptive identification of…
    Category
    Distribution
    25 states
  • SevereFDA (Devices)··2014-10-01

    Nanosphere Verigene Enteric Pathogens Test Recalled for Processing Errors

    Nanosphere is recalling 220 units of the Verigene Enteric Pathogens Nucleic Acid Test due to increased processing errors caused by Tip Holder Assemblies.

    Product
    The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence markers from liquid or soft stool preserved in Cary-Blair media, collected from…
    Category
    Distribution
    25 states
  • ModerateFDA (Devices)··2014-10-01

    Nanosphere Recalls Verigene Gram Negative Blood Culture Test Kits

    Nanosphere is recalling 400 units of the Verigene Gram Negative Blood Culture Nucleic Acid Test due to an increased rate of processing errors caused by tip holder assemblies.

    Product
    The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance…
    Category
    Distribution
    25 states
  • ModerateFDA (Devices)··2014-10-01

    Nanosphere Recalls Verigene Respiratory Virus Plus Test Due to Processing Errors

    Nanosphere is recalling Verigene Respiratory Virus Plus tests because Tip Holder Assemblies caused increased processing errors on the Processor SP.

    Product
    The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with…
    Category
    Distribution
    25 states