Beckman Coulter Inc.: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Recall Summary Beckman Coulter is recalling a software update (MicroScan LabPro V5.03 Panel Update 11) for five models of automated laboratory analyzers used to test how bacteria respond to antibiotics. The software contains incorrect calculations that may produce inaccurate results, potentially classifying resistant bacteria as susceptible to antibiotics. This recall affects medical laboratories across the United States that use these MicroScan analyzer systems.
- Recalling firm
- Beckman Coulter Inc.
- 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
- Reason
- Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-26
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/d90bc84c-caed-4c44-bf62-ddbffb26ee4e