bioMerieux, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1059-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

VITEK 2 Systems and VITEK 2 with MYLA.

Product Classification:

Class II

Date Initiated: March 29, 2022

Date Posted: May 18, 2022

Recall Number: Z-1059-2022

Event ID: 89929

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.

Status: Ongoing

Product Quantity: 21,757 systems

Code Information:

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.

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.

Voluntary or Mandated:

Voluntary: Firm initiated