MicroScan Neg MIC 3J REF C54814

FDA device recall Z-1772-2026 · posted 2026-04-03 · Open, Classified

Recall details

Recalling firm

Beckman Coulter, Inc.

Reason for recall

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

Action taken

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

Root cause

Process control

Status

Open, Classified

Product code

LTT

Quantity affected

688 boxes (20 panels per box)

Distribution

International distribution in the country of Japan.

Date initiated

2025-06-25

Date posted

2026-04-03

Location

West Sacramento, CA