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May 25, 2022
Company: bioMerieux, Inc. Date of Enforcement Report: 5/25/2022 Class II PRODUCT VITEK 2 automated system. Recall Number: V-0141-2022 REASON Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests to not include the user-corrected or AES-corrected interpretation. This can potentially lead to incorrect final screen/synergy test results...
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IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

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