VITEK 2 Systems and VITEK 2 with MYLA.
Reported: May 18, 2022 Initiated: March 29, 2022 #Z-1059-2022
Product Description
VITEK 2 Systems and VITEK 2 with MYLA.
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.
Details
- Recalling Firm
- bioMerieux, Inc.
- Units Affected
- 21,757 systems
- Distribution
- 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.
- Location
- Durham, NC
Frequently Asked Questions
What product was recalled? ▼
VITEK 2 Systems and VITEK 2 with MYLA.. Recalled by bioMerieux, Inc.. Units affected: 21,757 systems.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 18, 2022. Severity: Moderate. Recall number: Z-1059-2022.
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