medical Class II Updated 2022-05-18

bioMerieux, Inc. recalls VITEK 2 Systems and VITEK 2 with MYLA.

Recalled Product

VITEK 2 Systems and VITEK 2 with MYLA.

Hazard / Issue

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.

Issued by

FDA

Affected States: NC
Lot/Code Info: 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.
View official government recall

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