CLASS II ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report

REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US) recalled

Beckman Coulter is recalling REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic, distributed nationwide in the US. The recall was initiated on 26 Jun 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 15099590799243/ V5.03 Panel Update 11

Quantity recalled158 instruments

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2888-2026
FDA event ID: 99349
Recalling firm: Beckman Coulter, Brea, CA
Classification: Class II
Status: Ongoing
Recall initiated: 26 Jun 2026
FDA classified: 5 Aug 2026
Reported: 12 Aug 2026
Type: Voluntary: Firm initiated
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

26 Jun 2026	Recall initiated by company
5 Aug 2026	Classified by FDA	+40 days
12 Aug 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Alaska Alabama Arkansas California Colorado Delaware Florida Georgia Iowa Illinois Indiana Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi

Questions about this recall

Why was it recalled?

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

Which lots are affected?

UDI: 15099590799243/ V5.03 Panel Update 11

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 99349

This product is part of a recall event; the main page for the event is REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) recalled.

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026	CLASS II	REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) recalled	Beckman Coulter	Other	Nationwide

More recalls from Beckman Coulter

All 334

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
26 Aug 2026Device	CLASS II	DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter	Beckman Coulter	Packaging Defects	Nationwide
12 Aug 2026Device	CLASS II	REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) recalled	Beckman Coulter	Other	Nationwide
29 Apr 2026Device	CLASS II	Access Total T4 Calibrator recalled by Beckman Coulter	Beckman Coulter	Other	Nationwide
15 Apr 2026Device	CLASS II	MicroScan Neg Multidrug Resistant MIC recalled by Beckman Coulter	Beckman Coulter	Device Malfunction	CA

Other Other Medical Devices recalls

All 13,884

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	NOxBOXi Nitric Oxide Delivery System recalled	Noxbox	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Palacos R pro recalled by Heraeus Medical GmbH (Dental	Heraeus Medical GmbH (Dental Division)	Packaging Defects	Nationwide
7 Oct 2026Device	CLASS II	Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled	Percussionaire	Other	Nationwide
7 Oct 2026Device	CLASS II	Positron Emission Tomography and Computed Tomography System recalled	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire	Percussionaire	Other	Nationwide