CLASS II ONGOING Device recall · Reported 14 Oct 2026 · FDA Enforcement Report

DxC 500i Clinical Analyzer Modules: DxC 500 AU Module w/ISE recalled

Beckman Coulter is recalling DxC 500i Clinical Analyzer Modules: DxC 500 AU Module w/ISE, DxC 500i, distributed nationwide in the US. The recall was initiated on 2 Sep 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware version 1.3.5 or earlier. 1. UDI-DI 14987666545089 2. UDI-DI 14987666545072 3. UDI-DI 15099590742331

Quantity recalled146 US, 170 OUS

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-0083-2027
FDA event ID: 99800
Recalling firm: Beckman Coulter, Brea, CA
Classification: Class II
Status: Ongoing
Recall initiated: 2 Sep 2026
FDA classified: 2 Oct 2026
Reported: 14 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

2 Sep 2026	Recall initiated by company
2 Oct 2026	Classified by FDA	+30 days
14 Oct 2026	Published in enforcement report	+12 days

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

Reason for recall

Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyzer to revert the test units to the system default setting without notifying the user. The system does Pre-Review Reminders Include OII and [email protected] in any discussions on change/elevation of recalls to Class I classification and situations involving additional public communications (FDA and/or firm issued). Post-Review Reminders Final Check: Ensure your documentation accurately reflects the final recommendation prior to signature. Complete CTS: Recall Product tab, Additional Recall Event Info, Regulation, and Act. Upload PDFs of Consult, Review Memo, and Classification Letter for Class I Recall in DocMan. [Click to enter extra reminder]To add reminders, type the reminder in the text field to the left then press the Tab key. Doc ID 03534.05.06 2 of 8 not provide a warning or notification to alert the user that the configured units have reverted to the default units. This issue can result in falsely elevated reported results.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 Module, DxC 500i, Part No. C13252

Where it was distributed

Worldwide - US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Software version 1.3.5 or earlier. 1. UDI-DI 14987666545089 2. UDI-DI 14987666545072 3. UDI-DI 15099590742331

Where was it sold?

Worldwide - US Nationwide distribution.

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 21 Oct 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 99800

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026	CLASS II	DxC 500 AU Clinical Chemistry Analyzers: AU w/out ISE recalled	Beckman Coulter	Device Malfunction	Nationwide

More recalls from Beckman Coulter

All 336

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	DxC 500 AU Clinical Chemistry Analyzers: AU w/out ISE recalled	Beckman Coulter	Device Malfunction	Nationwide
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 # D23352, MicroScan LabPro V5.03 Panel Update 11 (US) recalled	Beckman Coulter	Other	Nationwide
12 Aug 2026Device	CLASS II	REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) recalled	Beckman Coulter	Other	Nationwide

Other Test Kits & Diagnostics recalls

All 2,663

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	DxC 500 AU Clinical Chemistry Analyzers: AU w/out ISE recalled	Beckman Coulter	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	McKesson Consult hCG Urine Cassette recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
7 Oct 2026Device	CLASS II	Systems/units containing affected recalled	Beckman Coulter Mishima K.K	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
30 Sep 2026Device	CLASS II	Vitek 2 Ast-N461 Test Kit, Gram Negative Susceptibility recalled	Biomerieux	Other	MO