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RecallWatchMedical Device Safety
Class IIOngoingZ-1794-2026

Beckman Coulter, Inc. recalls MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Inte…

Beckman Coulter, Inc.West Sacramento, CA, United StatesReported Apr 15, 2026 · 3 months ago
Legal News Analyst ·

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI-DI codeCatalog # Number
    Affected lot
    2026-05-08

What the firm is doing

On 09/08/2025, the firm sent via mail/email an "URGENT FIELD SAFETY NOTICE" to customers informing them that as a result of an internal investigation Beckman Coulter confirmed that Ciprofloxacin (Cp) antimicrobial agent was incorrectly manufactured on MicroScan Neg Multidrug Resistant MIC 1 Lot 2026-05-08. Customers are instructed to: "Review Ciprofloxacin results generated from Lot 2026-05-08 to identify any abnormal or unexpected trends in both susceptible and resistance patterns, or unexpected change in MIC trends, as compared to historical results for that same species (e.g. a sudden, unexplained increase in susceptible or % susceptible results for a species after implementation of Lot 2026-05-08 versus the previous susceptible or % susceptible results for the same species prior to using Lot 2026-05-08). "Discontinue use of this lot and discard per your laboratory guidelines "The laboratory should retain the inventory of other MicroScan Neg Multidrug Resistant MIC 1 lots as they are not impacted by this issue. Note-Beckman Coulter is no longer distributing MicroScan Neg Multidrug Resistant MIC 1 Lot 2026-05-08 For questions - contact Customer Support Center from website: http://www.beckmancoulter.com

DistributionShow details

International distribution to the country of Poland.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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