FDA recall, , Moderate risk
Beckman Coulter MicroScan Neg Multidrug Resistant MIC 1 Panels
MicroScan Neg Multidrug Resistant MIC 1 has a manufacturing issue with in vitro multidrug resistant test.
Summary by Recall Canary from the FDA notice
What happened
Beckman Coulter, Inc., of West Sacramento, California, recalled MicroScan Neg Multidrug Resistant MIC 1 REF C32368, a test used with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels for determining antimicrobial susceptibility of gram-negative bacilli.
The recall began September 8, 2025, due to a manufacturing issue with incorrectly processing the in vitro multidrug resistant test. The product was distributed internationally to Poland, and the FDA added it to its Enforcement Report on April 8, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
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
- UDI-DI
- 15099590720568
- Lot code
- 2026-05-08
Recall details
- Company began the recall
- Sold in
International distribution to the country of Poland.
- Company
- Beckman Coulter, Inc.West Sacramento, California
- Hazard
- Manufacturing problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98562
- Recall number
- Z-1794-2026
- Quantity recalled
- 3 boxes
All recalls from Beckman Coulter, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
