Recall Z-1794-2026 ยท LTT Panels, Test, Susceptibility, Antimicrobial
Beckman Coulter, Inc.
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.
| Date | Apr 8, 2026 (initiated Sep 8, 2025) |
| Status | Open, Classified |
| Reason | Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test. |
| Root cause | Under Investigation by firm |
| Action | 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, une |
| Quantity | 3 boxes |
| Distribution | International distribution to the country of Poland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.