Z-2888-2026Class II

REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments...

Name: Z-2888-2026 REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments...
Creator: Beckman Coulter Inc.
Published: 2026-06-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2026-06-26 / Open, Classified / root cause: software

FDA source

Beckman Coulter Inc. began a recall of REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments: - B1018-280 MicroScan autoSCAN-4 Instrument -... on 2026-06-26. FDA classified it as Class II and gives the reason as "Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2888-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-26
Posted: 2026-08-05
Recalling firm: Siemens Healthcare Diagnostics 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
Product code: LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Reason for recall: Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
Root cause tag: software
FDA root cause: Software Design Change
Action: 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.
Quantity in commerce: 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.
Product codes and lots: UDI: 15099590799243/ V5.03 Panel Update 11

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2888-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2888-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-05
Z-2889-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-05

Product code LON

K201405Class IILabPro Data Management SystemBeckman Coulter, Inc. / cleared 2020-08-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)