← FDA ENFORCEMENT
Z-1772-2026Class II
Beckman Coulter, Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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 & CAPAReason 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
2026-10-21Class IIHouston Rx LLC2026-10-21Class IICook Incorporated2026-10-21Class IIBaxter Healthcare Corporation2026-10-14Class IIQUANTUM OPS Inc
See all Risk Management & CAPA recalls →Data: U.S. FDA. 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. Open the enforcement explorer →