Recall Z-1794-2026
Beckman Coulter, Inc. · initiated September 8, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Catalog Number: C32368 UDI-DI code: 15099590720568 Lot Number: 2026-05-08
Reason for recall
Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
FDA-determined cause: Under Investigation by firm
Action taken
On 09/08/2025, the firm sent via mail/email an "URGENT FIELD SAFETY NOTICE" to customers informing them that as a result of an internal investigation Beckman Coulter confirmed that Ciprofloxacin (Cp) antimicrobial agent was incorrectly manufactured on MicroScan Neg Multidrug Resistant MIC 1 Lot 2026-05-08. Customers are instructed to: "Review Ciprofloxacin results generated from Lot 2026-05-08 to identify any abnormal or unexpected trends in both susceptible and resistance patterns, or unexpected change in MIC trends, as compared to historical results for that same species (e.g. a sudden, unexplained increase in susceptible or % susceptible results for a species after implementation of Lot 2026-05-08 versus the previous susceptible or % susceptible results for the same species prior to using Lot 2026-05-08). "Discontinue use of this lot and discard per your laboratory guidelines "The laboratory should retain the inventory of other MicroScan Neg Multidrug Resistant MIC 1 lots as they are not impacted by this issue. Note-Beckman Coulter is no longer distributing MicroScan Neg Multidrug Resistant MIC 1 Lot 2026-05-08 For questions - contact Customer Support Center from website: http://www.beckmancoulter.com
Details
- Recall number
- Z-1794-2026
- Initiated
- September 8, 2025
- Posted by FDA
- April 8, 2026
- Product code
- LTT – Panels, Test, Susceptibility, Antimicrobial
- Quantity
- 3 boxes
- Distribution
- International distribution to the country of Poland.
- Recalling firm
- Beckman Coulter, Inc., West Sacramento, CA