Recalls / —

—#219075

Product

MicroScan Neg MIC 3J REF C54814

FDA product code

LTT — Panels, Test, Susceptibility, Antimicrobial

Device class

Class 2

Medical specialty

Microbiology

Affected lot / code info

Catalog Number: C54814 UDI code: N/A Lot Number: 2025-08-23

Why it was recalled

Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics

Root cause (FDA determination)

Process control

Action the firm took

On 07/15/2024, firm sent via mail/email an "URGENT MEDICAL DEVICE RECALL" Letter to customer inform them that customers have reported multiple patient samples with skipped wells for Ceftolozane/Tazobactam (C/T) when tested with MicroScan Neg MIC 3J Lot 2025-08-23. The C/T 2/4 dilution well exhibited no growth while growth was observed in the C/T 4/4 well. Customers are instructed to: "Discontinue use of this lot and discard per your laboratory guidelines. "Consider reviewing the C/T antimicrobial susceptibility test results from this lot if Enterobacterales reported as resistant and P. aeruginosa reported as intermediate or if an increasing trend in resistance has been observed for C/T in your laboratory. "The laboratory should retain the inventory of other MicroScan Neg MIC 3J lots as they are not impacted by this issue. any questions regarding this notice, please contact us: "From our website: http://www.beckmancoulter.com "By phone: please contact: Customer call center TEL :0120-566-730

Recalling firm

Firm

Beckman Coulter, Inc.

Address

2040 Enterprise Blvd, West Sacramento, California 95691-3427

Distribution

Distribution pattern

International distribution in the country of Japan.

Timeline

Recall initiated

2025-06-25

Posted by FDA

2026-04-03

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #219075. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.