FDA-Device2026-04-15Class IIPROCESSING DEFECT
MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
Hazard
Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
Intended for
All ages
Illnesses reported
None reported
Sold states
International distribution to the country of Poland.
Affected count
3 boxes
Manufactured in
2040 Enterprise Blvd, West Sacramento, CA, United States
Products
MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1794-2026Want us to check the next one for you?
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