← FDA ENFORCEMENT
Z-1609-2026Class II

Beckman Coulter, Inc.

Recalling firm
Beckman Coulter, Inc.
Product type
Device
Status
Ongoing
Report date
2026-04-01
Distribution
U.S. Nationwide distribution in the states of CA, CO, IN, MA, MD, MN, MO, NC, NJ, OK, PA, and TX.
Firm state
CA
Product quantity
685 boxes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Due to the likely presence of contamination in well(s).

Product description

MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 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: C42464 UDI-DI code: 15099590731212 Lot Number: 2026-01-03

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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.