FDA Medical devices recall ·
MicroScan Neg Multidrug Resistant MIC 1 recall
- Recall number
- Z-1794-2026
- Date
- (initiated September 8, 2025)
- Company / brand
- Beckman Coulter, Inc.
2040 Enterprise Blvd, West Sacramento, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3 boxes
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog Number: C32368 UDI-DI code: 15099590720568 Lot Number: 2026-05-08
Distribution
International distribution to the country of Poland.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1794-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.