HIGH

Beckman Coulter MicroScan Neg MIC 56 Panels Recalled for Contamination Risk (2026)

Beckman Coulter recalled 685 boxes of MicroScan Neg MIC 56 panels distributed nationwide to U.S. healthcare facilities after contamination was reported in wells. Contamination could lead to unreliable antimicrobial susceptibility and organism-identification results. Health care providers should stop using the panels and follow Beckman Coulter recall instructions immediately.

Quick Facts at a Glance

Recall Date
July 24, 2025
Hazard Level
HIGH
Brand
Beckman Coulter
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Due to the likely presence of contamination in well(s).

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

Beckman Coulter MicroScan panels are used in clinical microbiology to assess antimicrobial susceptibility and identify bacteria to species level. The Neg MIC 56 panel is one variant used in labs for Gram-negative bacilli testing.

Why This Is Dangerous

If wells are contaminated, test results may be inaccurate, potentially leading to incorrect treatment decisions for patients.

Industry Context

This recall is not described as part of a broader industry pattern in the notice.

Real-World Impact

Laboratories may experience testing delays and must switch to safe alternatives. Inaccurate results can affect patient therapy decisions and outcomes.

Practical Guidance

How to identify if yours is affected

  1. Check for Catalog Number C42464 and UDI-DI 15099590731212 on packaging or documentation.
  2. Verify Lot Number 2026-01-03 on the box.
  3. Review recall notices and discontinue use of affected lots.

Where to find product info

Visit the FDA recall page linked in the notice and Beckman Coulter's recall communications for exact instructions.

What timeline to expect

Repair or replacement timelines typically follow supplier actions and hospital procurement schedules; expect several weeks.

If the manufacturer is unresponsive

  • Escalate to hospital regulatory affairs or procurement contacts.
  • File a formal complaint with the supplier and FDA if needed.

How to prevent similar issues

  • Implement a strict QA review of all lot numbers before use.
  • Maintain an updated recall dashboard for laboratory supplies.
  • Verify supplier recall statuses before accepting shipments.

Documentation advice

Keep copies of the recall notice, packaging, lot numbers, and communications with Beckman Coulter. Document testing results and when panels were removed from service.

Product Details

Catalog Number: C42464 UDI-DI: 15099590731212 Lot Number: 2026-01-03 Quantity: 685 boxes Distribution: Nationwide in CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, TX Sold Through: Healthcare facilities nationwide Sold Since: 2025-07-24 recall date Price: Unknown Source: FDA enforcement recall page (Z-1609-2026)

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 685 boxes recalled
  • Catalog Number C42464
  • UDI-DI 15099590731212
  • Lot Number 2026-01-03
  • Nationwide distribution across 12 states: CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, TX
  • Recall date 2025-07-24; status ACTIVE

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
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Catalog Number: C42464 UDI-DI code: 15099590731212 Lot Number: 2026-01-03
Affected States
ALL
Report Date
April 1, 2026
Recall Status
ACTIVE

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