Class IIPossible risk
VITEK: Automated microbiology system
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 at the LIS.
The recalled product
VITEK 2 automated system.
Codes on the package: Version 8.02
If you have this product, don’t eat it or feed it. Throw it away, or return it where you bought it.
- Status
- In progress (Ongoing)
- Type
- Pet food
- Recalled by
- bioMerieux, Inc.
- Posted by the FDA
- Started by the firm
- Classified
- Sold in
- Distribution was made to CA, IN, KS, MO, OH, PA, SC, TN, and TX, Foreign distribution was made to Australia, Austria, Canada, China, Germany, Guatemala, India, Ireland, Italy, Mexico, Papua New Guinea, Poland, Singapore, South Korea, Spain, Switzerland, Thailand, Turkey, and United Kingdom.
From the FDA
This recall is in the FDA’s Enforcement Report under recall number V-0141-2022. The headline above is a summary; the product descriptions are the FDA’s own words.