Recall Z-1772-2026— Beckman Coulter, Inc.

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2025-06-25. FDA's recall record names no specific 510(k) clearance for this event. Product: MicroScan Neg MIC 3J REF C54814. Reason: Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics.

Recalling firm
Beckman Coulter, Inc.
Classification
Class II
Status
Ongoing
Initiated
2025-06-25
Firm location
West Sacramento, CA, United States

Product description

MicroScan Neg MIC 3J REF C54814

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.