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Z-1794-2026Class 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 to the country of Poland.
Firm state
CA
Product quantity
3 boxes
Initiated by
Voluntary: Firm initiated
Reason for recall

Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.

Product description

MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

Code / lot info

Catalog Number: C32368 UDI-DI code: 15099590720568 Lot Number: 2026-05-08

Other recalls SPEQ maps to Documentation & Change Control
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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 →