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FDA · Medical devices ·

REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments recall

Beckman Coulter Inc. recalled REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments on August 12, 2026 because of analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications.". It was sold nationwide.

Why it was recalled

Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."

What's recalled

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

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Beckman Coulter Inc., Brea, CA
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
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.
Status
Ongoing
Recall number
Z-2889-2026
Source
U.S. Food and Drug Administration

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