Vitek 2 Compact

• 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. 12 Jul 2017 Recall initiated FDA recalls Z-3075-2017
4. 12 Jul 2017 Recall initiated FDA recalls Z-3076-2017
5. 13 Nov 2018 Recall initiated FDA recalls Z-0639-2019
6. 28 Jan 2021 Recall initiated FDA recalls Z-1307-2021
7. 28 Jan 2021 Recall initiated FDA recalls Z-1308-2021

510(k) Number

K050002 ↗

FDA product code

LON

Device class

Class II

Regulation

21 CFR Part 866.1645

Advisory committee

Microbiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation).

• SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE by Dade Behring, Inc.
• BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CLINDAMYCIN (STREP) 0.03125 -4 UG/ML by BECTON, DICKINSON & CO.
• MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - AMPICILLIN by Dade Behring, Inc.
• BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMIKACIN-0.5-64 UG/ML by BECTON, DICKINSON & CO.
• Antimicrobial Susceptibility Test System by Abbott Laboratories
• MICROSCAN SYNERGIES PLUS by Dade Microscan, Inc.
• BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL) by Becton, Dickinson and Company
• BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML) by Becton, Dickinson and Company
• Colibrí by Copan Wasp Srl
• LabPro Data Management System by Beckman Coulter, Inc.

• VITEK REVEAL SOFTWARE v1.3 CONTROL

  Class II

  CE/IVDR FDA 510(k) ×2 Active Cleared 20 Jun 2024 +1authorizations

• Vitek® 2 Ast-N816 Open recall

  Class II

  FDA 510(k) ×5 Active Cleared 19 Dec 2017 GUDID on market

• Columbia Sheep Blood Agar 5%

  Class I

  FDA 510(k) K830075 Active Cleared 9 Feb 1983

• Brain Heart Infusion Broth

  Class I

  FDA 510(k) K844529 Active Cleared 7 Jan 1985

See all devices from Biomerieux, Inc. →