Biomerieux Recalls VITEK 2 Compact Systems Due to HL7 Software Defect
Biomerieux is recalling VITEK 2 Compact systems because a software defect in HL7 communication may prevent expertised interpretation results from being sent to Laboratory Information Systems.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of erroneous test results (false susceptible) which could impact patient care, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomerieux Inc is recalling 6,777 VITEK 2 Compact systems (versions 8.01, 8.02, 9.01, and 9.02) configured with HL7 external communication. The recall is due to a software defect that can prevent the system from sending expertised interpretation results and Therapeutic Corrections (TC) to Laboratory Information Systems (LIS) when an isolate is sent more than once.
The defect may cause results in the VITEK 2 instrument to not match the results sent to the LIS. In the worst case, this could lead to a false susceptible erroneous test result. Laboratory technicians may need to manually change results in the LIS to match those in the VITEK 2.
The affected systems were distributed worldwide, but no US consignees are affected. The recall covers specific countries including Andorra, Austria, Bangladesh, and others listed in the distribution pattern. Users should contact Biomerieux for instructions on how to address the software defect.
The recalled product
- Product
- VITEK 2 Compact (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 incubation). VITEK 2 is an automated system consisting of instruments, software and reagent…
- Manufacturer
- Biomerieux Inc
- Affected units
- 6,777
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- VITEK 2 and VITEK 2 Compact (version numbers 8.01
- 8.02 (8.0x) and 9.01
- Reference Number: 27560
- Catalog Number: C57
- UDI: 03573026136796)
- (System: VITEK 2 Compact 30
- Reference Number: 27560R
- UDI: 03573026147501)
- Reference Number: 27530
- UDI: 03573026136789)
- Reference Number: 27530R
- UDI: 03573026147495)
- (System: VITEK 2 Compact 15
- Reference Number: 27415
- UDI: 03573026220624)
- Reference Number: 27415R
- UDI: 03573026220631)
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Biomerieux Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Biomerieux Inc
See all →- HighBiomerieux VITEK 2 AST-N461 Test Kit Recalled for Card Pouch Damage
FDA (Devices) · 2026-09-30
- HighVITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results
FDA (Devices) · 2026-07-15
- HighSusceptibility test cards recalled over false resistant antibiotic results
FDA (Devices) · 2026-02-11
- HighAntimicrobial susceptibility test cards recalled over false colistin resistance results
FDA (Devices) · 2025-10-08
- SevereVITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk
FDA (Devices) · 2024-05-01
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI 550 PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Similar recalls
- HighBiomerieux VITEK 2 Compact Computer System Recall for Patient Data Error
FDA (Devices) · 2013-04-03
- ModerateBioMérieux Vitek 2 Software Version 6.01 Recalled for Interface Errors
FDA (Devices) · 2013-08-14
- HighbioMerieux Recalls VITEK 2 Systems Software Version 9.01 Update Kit
FDA (Devices) · 2018-12-26
- ModerateBiomerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors
FDA (Devices) · 2013-08-14
- ModerateBioMerieux Vitek 2 Software Recall for Antibiotic Code Errors
FDA (Devices) · 2013-08-14
- ModerateBioMerieux Vitek 2 Software Recall for Interface Code Errors
FDA (Devices) · 2013-08-14