—#192933

Product

VITEK 2 Systems and VITEK 2 with MYLA.

FDA product code: LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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

Recalling firm

Firm: bioMerieux, Inc.
Address: 100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2022-03-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192933. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.