[Recalled] VITEK 2 Systems and VITEK 2 with MYLA. — Software issue where results sent to the LIS via HL7 format for antibiotic scre… | FDA 2022-03-29

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from bioMerieux, Inc.

• MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)). — Class II
• BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical systems. Specifically the — Class II
• VITEK¿ 2 Systems Software Version 9.01 Update Kit. — Class II
• BacT/ALERT¿ SN, bioM¿rieux, Inc. Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast). — Class II
• VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 421913 Product Usage: VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimic — Class II
• VIDAS RUB IgG (RBG), REF 30226 — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.