bioMerieux, Inc. 2022-05-18 Health serious FDA
Health · FDA · Recall #FDA-Z-1059-2022
VITEK 2 Systems and VITEK 2 with MYLA. Recall
Issued May 18, 2022 · bioMerieux, Inc.
In May 2022, bioMerieux, Inc. recalled the VITEK 2 Systems and VITEK 2 with MYLA., a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using VITEK 2 Systems and VITEK 2 with MYLA. right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact bioMerieux, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- bioMerieux, Inc.
- Category
- Health
- Recall date
- May 18, 2022
- Units affected
- Not reported
- Sold at
- U.S. distribution of the FSCA to NC. OUS distribution of the FSCA to subsidiaries in Argentina, Australia, Austria, Belgium, Brazil, Canada
- Recall number
- FDA-Z-1059-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- bioMerieux, Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.