Z-1059-2022Class II

VITEK 2 Systems and VITEK 2 with MYLA

Name: Z-1059-2022 VITEK 2 Systems and VITEK 2 with MYLA
Creator: bioMerieux, Inc.
Published: 2022-03-29
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2022-03-29 / Open, Classified / root cause: software

FDA source

bioMerieux, Inc. began a recall of VITEK 2 Systems and VITEK 2 with MYLA on 2022-03-29. FDA classified it as Class II and gives the reason as "Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This can potentially lead to incorrect final...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1059-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-29
Posted: 2022-05-11
Recalling firm: bioMerieux, Inc.
Product: VITEK 2 Systems and VITEK 2 with MYLA.
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Reason for recall: Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This can potentially lead to incorrect final screen/synergy test results at the LIS.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm issued Field Safety Corrective Action (FSCA) #5615 dated 29-MAR-2022 to the impacted subsidiaries and distributors. It explained the affected product, issue, and informed the recipient the resolution for the issue has been implemented in VITEK 2 Systems software maintenance release 9MR3 launched 15-MAR-2022 and available in VILINK. It was recommended to convert HL7 users to VITEK 2 Software Version 9.03 and apply the software patch 9MR3 as quickly as possible. Workarounds were provided pending installation of 9MR3 to ensure there are no adverse impact to patients. The FSCA provided a risk assessment/health hazard assessment. The FSCA reported the VITEK 2 Systems software versions 8.01, 8.02, 9.01, 9.02, and 9.03 are available for distribution worldwide, however, only HL7 Protocol users may be impacted by the issue. All subsidiaries and distributors were listed in the FSCA. Their required actions included: (1) Immediately acknowledge receipt of this FSCA; (2) Identify all countries and customers for which they are responsible that are impacted by this FSCA (only HL7/BCI Connect users); (3) Update the enclosed Urgent Product Correction Notice and Customer Acknowledgment Form to include their local contact information and translate them, if necessary; (4) Distribute the Urgent Product Correction Notice and Customer Acknowledgement Form to all VITEK 2 HL7 customers; (5) Determine regulatory reporting requirements in accordance with local regulations and notify regulatory authorities as applicable; (6) The subsidiary/distributor is responsible to monitor action completion at customer sites and determine requirements for local closure of this FSCA in accordance with local regulations and procedures; (7) After all actions are complete, return the acknowledgement of completion for this FSCA. The due date for completion of the required actions and submitting the acknowledgment of completion is 29-JUN-2022. Additionally, Subsidiaries and Distribut
Quantity in commerce: 21,757 systems
Distribution: U.S. distribution of the FSCA to NC. OUS distribution of the FSCA to subsidiaries in Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Serbia, Sweden, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, and United Kingdom.
Product codes and lots: VITEK 2 - Versions 8.01, 9.01, 9.02 (with or without 9MR2), 9.03 (with or without #9MR2). VITEK 2 with MYLA - Versions 4.8 and 4.9.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1059-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1059-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-18	2022-05-11

Product code LON

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)