Beckman Coulter MicroScan LabPro Panel Update Software
MicroScan LabPro V5.03 Panel Update 11 has incorrect algorithms that may affect antimicrobial susceptibility test results.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Beckman Coulter Inc., of Brea, California, recalled MicroScan LabPro V5.03 Panel Update 11 DVD Kit and MicroScan LabPro V5.03 Panel Update 11 (US) because analyzers contain incorrect algorithms that may affect antimicrobial susceptibility test results, leading to false susceptibility classifications. The recall began June 26, 2026, and was added to the FDA's Enforcement Report on August 5, 2026.
The products were distributed nationwide in the United States, including in states such as Alaska, California, Florida, and Texas.
Summary by Recall Canary from the FDA notice.
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 your kit affected?
2 products
Affected if its UDI-DI is listed.
REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on
- UDI-DI
- 15099590799250
REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on
- UDI-DI
- 15099590799243
Details
- Company began the recall
- Sold in
US Nationwide distribution including in the states of Alaska, Alabama, Arkansas, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Wisconsin, West Virginia, Wyoming.
- Event ID
- 99349
- Recall numbers
- Z-2888-2026 to Z-2889-2026
- Company
- Beckman Coulter Inc.Brea, California
- Hazard
- Software defect
- Recall type
- Voluntary: Firm initiated
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
