—#219085

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.

FDA product code: LTT — Panels, Test, Susceptibility, Antimicrobial
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: Catalog Number: C32368 UDI-DI code: 15099590720568 Lot Number: 2026-05-08

Why it was recalled

Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 2040 Enterprise Blvd, West Sacramento, California 95691-3427

Distribution

Distribution pattern: International distribution to the country of Poland.

Timeline

Recall initiated: 2025-09-08
Posted by FDA: 2026-04-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #219085. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.