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U.S. Department of Health and Human Services

Class 2 Device Recall MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US)

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 Class 2 Device Recall MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US)see related information
Date Initiated by FirmJune 26, 2026
Date PostedAugust 05, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2889-2026
Recall Event ID 99349
510(K)NumberK201405 
Product Classification System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
ProductREF # 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 UDI: 15099590799250/ V5.03 Panel Update 11
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information ContactKurtis Montegna
714-961-5321
Manufacturer Reason
for Recall		Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
FDA Determined
Cause 2		Software Design Change
ActionBetween 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.
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LON
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