CLASS II ONGOING Device recall · Reported 7 Oct 2026 · FDA Enforcement Report

Systems/units containing affected recalled

Beckman Coulter Mishima K.K is recalling Systems/units containing affected, distributed nationwide in the US. The recall was initiated on 3 Aug 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProducts containing affected software: Item Numbers / UDI-DI codes: Item Number: B96692 UDI-DI code: 14987666542965 Item Number: B96693 UDI-DI code: 14987666542972 Item Number: B12183 UDI-DI code: 14987666540671 Item Number: N3151400 UDI-DI code: Due to the age of the device and the fact that it has exceeded its storage period, the UDI number is not available.)

Quantity recalled492 units

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-3332-2026
FDA event ID: 99588
Recalling firm: Beckman Coulter Mishima K.K, Sunto-Gun
Classification: Class II
Status: Ongoing
Recall initiated: 3 Aug 2026
FDA classified: 30 Sep 2026
Reported: 7 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

3 Aug 2026	Recall initiated by company
30 Sep 2026	Classified by FDA	+58 days
7 Oct 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

Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the instrument software, using PC pre-installed with Microsoft SQL Server 2022 Express. When this occurs, AlarmDB becomes unreadable and the instrument software cannot be started. This causes a delay in obtaining patient 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

Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965 B96693 / 14987666542972 B12183 / 14987666540671 The AU480 Chemistry Analyzer measure analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material, and other accessories. This system is for in vitro diagnostic use only.

Where it was distributed

Worldwide - U.S. Nationwide distribution in the states of AR, CA, DE, FL, GA, GU, HI, IA, IL, IN, KS, KY, MN, MO, NC, NM, NY, OK, PA, SD, TX, and WI. The countries of Algeria, Australia, Belarus, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Costa Rica, Croatia, Cyprus, Czechia, Egypt, France, Germany, Guatemala, Hungary, India, Ireland, Italy, Japan, Kazakhstan, Korea, Republic of, Latvia, Malaysia, Morocco, Myanmar, Nepal, Nigeria, Pakistan, Poland, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, South Africa, Taiwan, Province of China, Turkey, United Arab Emirates, and Viet Nam.

Nationwide Arkansas California Delaware Florida Georgia Hawaii Iowa Illinois Indiana Kansas Kentucky Minnesota Missouri North Carolina New Mexico New York Oklahoma Pennsylvania South Dakota Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

Products containing affected software: Item Numbers / UDI-DI codes: Item Number: B96692 UDI-DI code: 14987666542965 Item Number: B96693 UDI-DI code: 14987666542972 Item Number: B12183 UDI-DI code: 14987666540671 Item Number: N3151400 UDI-DI code: Due to the age of the device and the fact that it has exceeded its storage period, the UDI number is not available.)

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 13 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Beckman Coulter Mishima K.K

All 7

Reported	Class	Recall	Company	Reason	Where
18 Mar 2026Device	CLASS II	DxC 700 AU recalled by Beckman Coulter Mishima K.K	Beckman Coulter Mishima K.K	Device Malfunction	Nationwide
18 Mar 2026Device	CLASS II	Chemistry Analyzer Au5800 recalled by Beckman Coulter Mishima K.K	Beckman Coulter Mishima K.K	Device Malfunction	Nationwide
11 Jun 2025Device	CLASS II	Sample probe sucks a sample dispensed into a tube or cup recalled	Beckman Coulter Mishima K.K	Device Malfunction	Nationwide
11 Jun 2025Device	CLASS II	Sample probe sucks a sample dispensed into a tube or cup recalled	Beckman Coulter Mishima K.K	Device Malfunction	Nationwide
28 Aug 2024Device	CLASS II	DxC 500 AU Clinical Chemistry Analyzer recalled	Beckman Coulter Mishima K.K	Device Malfunction	Nationwide

Other Test Kits & Diagnostics recalls

All 2,661

Reported	Class	Recall	Company	Reason	Where
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	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
23 Sep 2026Device	CLASS II	DASH Rapid PCR Instrument recalled by Nuclein	Nuclein	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	STA Staclot Protein recalled by Diagnostica Stago	Diagnostica Stago	Potency & Assay	Nationwide