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VITEK®2 Compact 27530RRecalls & reported problems

Biomerieux , Inc. · VITEK® 2 COMPACT 30 is an automated system that performs bacterial ID and AST. A total of 30 ID and/or AST cards can be processed simultaneously per run. · Class 2

All models of VITEK2 Compact (3)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

5 other recalls cover devices cleared under the same FDA submission (K050002); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

  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 · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050002. One submission often covers many models, so check the product and lot details in each record.

  • Z-1307-2021 · Jan 28, 2021 · Terminated
    VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short inc
  • Z-0639-2019 · Nov 13, 2018 · Terminated
    VITEK 2 Systems Software Version 9.01 Update Kit.
  • Z-3075-2017 · Jul 12, 2017 · Terminated
    VITEK 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and ye
  • Z-3076-2017 · Jul 12, 2017 · Terminated
    VITEK 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for the identification (ID) and antimicrobial sus
  • Z-0991-2013 · Feb 18, 2013 · Terminated
    VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models: (1) dc7100 8-port, Cat. #W0441; (2) dc7100 8-port (refurbished), Cat. #W0441R; (3) dc

Other System, Test, Automated, Antimicrobial Susceptibility, Short Incubation devices

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Sources and updates

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