← FDA ENFORCEMENT
Z-1772-2026Class II

Beckman Coulter, Inc.

Recalling firm
Beckman Coulter, Inc.
Product type
Device
Status
Ongoing
Report date
2026-04-15
Distribution
International distribution in the country of Japan.
Firm state
CA
Product quantity
688 boxes (20 panels per box)
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

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

Product description

MicroScan Neg MIC 3J REF C54814

Code / lot info

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

Other recalls SPEQ maps to Risk Management & CAPA
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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.