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bioMerieux, Inc. Recall 89929

Description: VITEK 2 Systems and VITEK 2 with MYLA.

bioMerieux, Inc. Recall 89929 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1059-2022
Event ID89929
Event DescriptionVITEK 2 Systems and VITEK 2 with MYLA.
Product TypeDevices
DistributionU.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.
Quantity21,757 systems
Recall ReasonSoftware 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.
Device Classification20220518
Device Code InfoVITEK 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.
Center Classification Date20220511
Recall Initiation Date20220329
Recalling FirmbioMerieux, Inc.
Initial Notification Letter
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