Vitek® 2 Compact 27415

• EUDAMED Basic UDI-DI 357302BUDI000560TM registered 21 Jul 2026 Active
• FDA 510(k) K050002 decided 17 Feb 2005 Active
• FDA GUDID UDI-DI 03573026220624 listed 14 Sep 2016 Listed

• 2 recalls, same reason

  • Terminated Z-1307-2021 FDA Class II ·initiated 28 Jan 2021
  • Terminated Z-1308-2021 FDA Class II ·initiated 28 Jan 2021

  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).

• • Terminated Z-0639-2019 FDA Class II ·initiated 13 Nov 2018

  The VITEK 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the VITEK 2 FLEXPREP" feature.

• 2 recalls, same reason

  • Terminated Z-3075-2017 FDA Class II ·initiated 12 Jul 2017
  • Terminated Z-3076-2017 FDA Class II ·initiated 12 Jul 2017

  Customers have reported that some VITEK 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be processed. The issue was reported to occur on VITEK 2 Compact 15 and Compact 30 systems following a system software update to version 8.01.

• • Terminated Z-0991-2013 FDA Class II ·initiated 18 Feb 2013 ·on shared 510(k) K050002

  There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 17 Feb 2005 Cleared FDA 510(k) K050002
2. 18 Feb 2013 Recall initiated FDA recalls Z-0991-2013
3. 14 Sep 2016 Listed FDA GUDID 03573026220624
4. 12 Jul 2017 Recall initiated FDA recalls Z-3075-2017
5. 12 Jul 2017 Recall initiated FDA recalls Z-3076-2017
6. 13 Nov 2018 Recall initiated FDA recalls Z-0639-2019
7. 28 Jan 2021 Recall initiated FDA recalls Z-1307-2021
8. 28 Jan 2021 Recall initiated FDA recalls Z-1308-2021
9. 21 Jul 2026 Registered EUDAMED 357302BUDI000560TM

Trade name

Vitek® 2 Compact

Generic name

Microorganism identification/antimicrobial-susceptibility analyser IVD

Model / reference

27415

Primary DI / UDI-DI

03573026220624

Basic UDI-DI

357302BUDI000560TM

510(k) Number

K050002 ↗

FDA product code

LON

EMDN code

W0203010180 Antibiotic susceptibility analysers - hardware accessories

GMDN term

Microorganism identification/antimicrobial-susceptibility analyser IVD

Device class

Class A EUDAMED

Class II GUDID

Regulation number

866.1645

EU registration type

Standard device

EU market of registration

France

GUDID distribution status

In Commercial Distribution

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Category: Microorganism identification/antimicrobial-susceptibility analyser IVD

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