MicroScan recallZ-2889-2026 · Beckman Coulter Inc. · initiated Jun 26, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
FDA root cause category: Software Design Change
What the company is doing
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.
Recall details
- Recall number
- Z-2889-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 26, 2026
- Posted by the FDA
- Aug 5, 2026
- Recalling firm
- Beckman Coulter Inc.
- Product code
- LON
- FDA submissions
- K201405
- 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.
Product 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
Code information (models, lots, serial numbers)
UDI: 15099590799250/ V5.03 Panel Update 11
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MicroScan V5.03 PU11Beckman Coulter, Inc. · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K201405 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- MicroScan V5.03 PU11EBeckman Coulter, Inc. · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99349).
- Z-2888-2026 · Open, ClassifiedREF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument - B1018-283 MicroScan Wa…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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