bioMerieux, Inc. recalls VITEK 2 Systems and VITEK 2 with MYLA.
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…
Read the official notice →- Date
- 2022-05-18
- Country
- United States
- Brand
- Biomerieux
- Product
- VITEK 2 Systems and VITEK 2 with MYLA.
- Classification
- Class II
- Units
- U.S. distribution of the FSCA to NC. OUS distribution of the FSCA to…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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There are 7 reported software anomalies that may affect use of the device.
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Other drugs & medical recalls in the United States
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