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.
Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
From the FDA notice · Read the official notice ↗ · All Beckman Coulter recalls
What to do
The agency's notice has the remedy and who to contact.
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- Product
- 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.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 3 boxes
- Illnesses reported
- None reported
- Manufactured in
- 2040 Enterprise Blvd, West Sacramento, CA, United States
- Classification
- Class II
- Recall number
- Z-1794-2026
In the FDA's words
- Description
- 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. Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test. Catalog Number: C32368 UDI-DI code: 15099590720568 Lot Number: 2026-05-08 Distribution: International distribution to the country of Poland. Affected quantity: 3 boxes
- Hazard
- Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
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