VITEK2 CompactRecalls & reported problems across all models

We found 3 models of VITEK2 Compact by Biomerieux , Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

VITEK2 Compact recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 28, 2021Terminated

   bioMrieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. The problem is when HL7 Connection is used, the results in the VITEK 2 do not match the results sent to the LIS and the Laboratory Technician would need to change results in the LIS to match those in the VITEK 2. If the isolate is sent more than once to LIS, a software defect prevents the system from sending the expertised interpretation results and the Therapeutic Corrections (TC) is not sent to Laboratory Information Systems (LIS).

   Z-1308-2021 · Root cause: Software design · names 3 of these models · Recall details · FDA record ↗

VITEK2 Compact models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VITEK®2 Compact 27530R

  System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
  1 recall0 reports
• VITEK®2 Compact 27560R

  System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
  1 recall0 reports
• VITEK®2 Compact 27415R

  System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
  1 recall0 reports

Other Biomerieux , Inc. products

• BACT/ALERT VIRTUO2 models · 41 reports · 2 recalls
• VITEK25 models · 2 reports · 2 recalls
• VITEK 2 COMPACT3 models · 25 reports · 1 recall