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U.S. Department of Health and Human Services

Class 2 Device Recall MicroScan Neg Multidrug Resistant MIC 1

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 Class 2 Device Recall MicroScan Neg Multidrug Resistant MIC 1see related information
Date Initiated by FirmSeptember 08, 2025
Date PostedApril 08, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1794-2026
Recall Event ID 98562
Product Classification Panels, test, susceptibility, antimicrobial - Product Code LTT
ProductMicroScan 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 Information Catalog Number: C32368 UDI-DI code: 15099590720568 Lot Number: 2026-05-08
FEI Number 2919016
Recalling Firm/
Manufacturer		 Beckman Coulter, Inc.
2040 Enterprise Blvd
West Sacramento CA 95691-3427
For Additional Information ContactKurtis Montegna
530-990-3496
Manufacturer Reason
for Recall		Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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
Quantity in Commerce3 boxes
DistributionInternational distribution to the country of Poland.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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