bioMerieux, Inc. VITEK 2 Systems and VITEK 2 with MYLA. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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

Distribution

As reported by FDA

IN, NC