Beckman Coulter Inc.: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Recall Summary Beckman Coulter is recalling several MicroScan laboratory analyzer models because they contain incorrect algorithms that may produce inaccurate antimicrobial susceptibility test results, potentially showing bacteria as susceptible to antibiotics when they may not be. The recall affects five analyzer models distributed nationwide across the United States. This is classified as a Class II recall, meaning the problem could result in serious health consequences but is unlikely to cause death.
- Recalling firm
- Beckman Coulter Inc.
- Product
- REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed 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/bf5a81b7-5cc9-4519-819b-0778859f0543