HIGH

Beckman Coulter MicroScan Neg Multidrug Resistant MIC 1 C32368 Recall Expands Internationally (2025)

Beckman Coulter recalled three boxes of MicroScan Neg Multidrug Resistant MIC 1 panels distributed internationally, including Poland. A manufacturing issue caused incorrect processing in in vitro multidrug resistance testing. Healthcare providers and patients should stop using the device immediately and follow manufacturer instructions for recall communications.

Quick Facts at a Glance

Recall Date
September 8, 2025
Hazard Level
HIGH
Brand
Beckman Coulter
Category
Health & Personal Care
Sold At
Unknown
At-Risk Groups
GENERAL, PREGNANT, PETS

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Beckman Coulter, Inc. or your healthcare provider for instructions. Notification method: Letter

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About This Product

MicroScan panels are used in clinical labs to determine antimicrobial susceptibility and species identification for gram-negative bacteria.

Why This Is Dangerous

A manufacturing issue in how the multidrug resistance test is processed can affect test accuracy, potentially impacting patient treatment decisions.

Industry Context

This recall highlights ongoing quality control challenges in diagnostic testing panels.

Real-World Impact

Potential misclassification of resistance can influence antibiotic choices and patient outcomes.

Practical Guidance

How to identify if yours is affected

  1. Check if your facility uses MicroScan Neg Multidrug Resistant MIC 1 Catalog C32368
  2. Verify UDI-DI 15099590720568 and Lot 2026-05-08
  3. Confirm purchase or inventory records for 3 boxes
  4. Compare with recall notice materials

Where to find product info

FDA recall page Z-1794-2026 and Beckman Coulter communications

What timeline to expect

Recall notices typically include timelines for return or replacement; contact Beckman Coulter for specifics

If the manufacturer is unresponsive

  • Document all attempts to contact Beckman Coulter
  • Contact FDA MedWatch if manufacturer remains unresponsive
  • Consider consulting hospital risk management

How to prevent similar issues

  • Regularly audit inventory for recalled diagnostic panels
  • Establish supplier recall processes and verify lot numbers prior to use
  • Ensure staff are trained to halt use when a recall is issued

Documentation advice

Keep recall notices, purchase records, inventory lists, and correspondence with the manufacturer

Product Details

Brand: Beckman Coulter. Product: MicroScan Neg Multidrug Resistant MIC 1. Catalog Number: C32368. UDI-DI: 15099590720568. Lot Number: 2026-05-08. Quantity: 3 boxes. Distribution: International, including Poland.

Reported Incidents

No specific injuries or incidents are reported in the recall notice.

Key Facts

  • 3 boxes recalled
  • UDI-DI 15099590720568
  • Catalog Number C32368
  • Lot 2026-05-08
  • Poland among international distribution
  • Class II recall (HIGH hazard)

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTPETS
Injury Types
OTHER

Product Details

Model Numbers
Catalog Number: C32368 UDI-DI code: 15099590720568 Lot Number: 2026-05-08
Report Date
April 15, 2026
Recall Status
ACTIVE

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