Recall Z-2888-2026
Beckman Coulter Inc. · initiated June 26, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: UDI: 15099590799243/ V5.03 Panel Update 11
Reason for recall
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
FDA-determined cause: Software Design Change
Action taken
Between the dates of June 26 -29, 2026, Beckman Coulter issued a Urgent Medical Device via Email and US Mail. Beckman Coulter ask consignees to take the following actions: 1. Manually verify results from the panels and assays listed below for Daptomycin or Cefepime when read with the WalkAway instrument or autoSCAN-4 instrument and for Vancomycin when read with the autoSCAN-4 instrument. 2. Continue routine quality control procedures, review flagged or unusual panel results and follow laboratory verification practices prior to reporting results. 3. Beckman Coulter recommends sharing the content of this letter with your laboratory and/or medical director regarding the need to review previous patient test results. 4. Beckman Coulter recommends posting this letter on or near the affected analyzers.
Details
- Recall number
- Z-2888-2026
- Initiated
- June 26, 2026
- Posted by FDA
- August 5, 2026
- Product code
- LON – System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- Quantity
- 158 instruments
- 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.
- Recalling firm
- Beckman Coulter Inc., Brea, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2889-2026 Class II | REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following…Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading… | 06/26/2026Open, Classified |