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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Beckman Coulter
- Product type
- Microbiology or Diagnostic Test Panel
- Model numbers
- Catalog Number: C32368 UDI-DI code: 15099590720568 Lot Number: 2026-05-08
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 8, 2025
Reported by FDA DEVICE
April 15, 2026
RecallRadar source check
April 22, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Check if your facility uses MicroScan Neg Multidrug Resistant MIC 1 Catalog C32368
- Confirm purchase or inventory records for 3 boxes
- 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
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
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
- Catalog Number C32368
- Poland among international distribution
- Class II recall (HIGH hazard)
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.