MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan
Summary
The FDA issued a Class II for MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 by Beckman Coulter, Inc.. Reason: Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test..
Details
Source
Device Recall
External ID
Z-1794-2026
Action Date
2026-04-15
Status
Ongoing
Category
device
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.
Lot/Code Info: Catalog Number: C32368 UDI-DI code: 15099590720568 Lot Number: 2026-05-08
Quantity Affected: 3 boxes
Reason for Recall
Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.
Distribution
International distribution to the country of Poland.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-08
Company
West Sacramento, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 232 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beckman Coulter, Inc. has 158 FDA actions in our database, including 111 recalls and 47 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beckman Coulter, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beckman Coulter, Inc. have FDA actions?
Beckman Coulter, Inc. has 158 FDA actions in our database, including 111 recalls and 47 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1794-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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