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
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
- MicroScan Neg MIC 56 Panels
- Model numbers
- Catalog Number: C42464 UDI-DI code: 15099590731212 Lot Number: 2026-01-03
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 24, 2025
Reported by FDA DEVICE
April 1, 2026
RecallRadar source check
April 8, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Check for Catalog Number C42464 and UDI-DI 15099590731212 on packaging or documentation.
- Verify Lot Number 2026-01-03 on the box.
- 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.
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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
- Catalog Number C42464
- Nationwide distribution across 12 states: CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, TX
- Recall date 2025-07-24; status ACTIVE
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Safety Guide
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