Beckman Coulter MicroScan LabPro panel update recalled for incorrect results
Beckman Coulter is recalling the MicroScan LabPro V5.03 Panel Update 11 DVD kit used on certain MicroScan analyzers. The software algorithms may produce incorrect antimicrobial susceptibility results, which could lead to bacteria being labeled as susceptible or resistant to a drug when they are not.
From the FDA notice · Read the official notice ↗ · All Beckman Coulter recalls
What to do
- Laboratories using affected MicroScan analyzers should contact Beckman Coulter for guidance on the update.
- Review recent antimicrobial susceptibility results generated with this panel update if concerns arise.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-496 DxM-1096 MicroScan WalkAway Instrument
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Illnesses reported
- None reported
- Manufactured in
- 250 S Kraemer Blvd, Brea, CA, United States
- Classification
- Class II
- Recall number
- Z-2889-2026
In the FDA's words
- Description
- REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan WalkAway-40 plus Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-496 DxM-1096 MicroScan WalkAway Instrument Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." UDI: 15099590799250/ V5.03 Panel Update 11 Distribution: US Nationwide distribution including in the states of AK, AL, AR, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WI, WV, WY.
- Hazard
- Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
More from Beckman Coulter
See all- Beckman Coulter DxC 500i analyzers recalled over software defect
ModerateFDAAug 26, 2026