—#219076

Product

MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 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
510(k) numbers: K202343
Affected lot / code info: Catalog Number: C42464 UDI-DI code: 15099590731212 Lot Number: 2026-01-03

Why it was recalled

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

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

On 07/24/2025, the firm sent via mail/email an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that Beckman Coulter has received reports that when testing clinical isolates there was no growth observed in Ceftazidime (Caz) 1, 8 and 16 mg/mL wells; however, growth was observed in the 4 mg/mL well with multiple panels from this lot. Upon further investigation, it was confirmed the growth was Bacillus spp. and not the clinical isolates being tested. Customers are instructed to: -Consider reviewing previous Caz antimicrobial test results from this lot for any spot growth detection (e.g., isolates with no growth in in Caz 1, 8 and 16 mg/mL wells and growth in the 4 mg/mL well or if there is an unusual increase in Caz MIC values). -Discontinue use of MicroScan Neg MIC 56 Lot 2026-01-03 For any questions regarding this notice, contact Customer Technical Support: -From our website: http://www.beckmancoulter.com -By phone: call 800 677-7226 option 1 in the United States. If replacement product is needed: -Complete the attached Replacement Order Form and email to askbeckman@beckman.com or fax to (866) 294-7850 OR -Call Client Services at (800) 526-3821

Recalling firm

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

Distribution

Distribution pattern: U.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.

Timeline

Recall initiated: 2025-07-24
Posted by FDA: 2026-03-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #219076. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.