CLASS II ONGOING Device recall · Reported 10 Apr 2019 · FDA Enforcement Report

UniCel DxC 660i, 680i, 860i recalled by Beckman Coulter

Beckman Coulter is recalling UniCel DxC 660i, 680i, 860i, and 880i Synchron Access Clinical Systems, that are, distributed in 26 states. The recall was initiated on 5 Dec 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSystems running software versions: 5.2, 5.3.0, 5.3.1.

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-1078-2019
FDA event ID: 82079
Recalling firm: Beckman Coulter, Brea, CA
Classification: Class II
Status: Ongoing
Recall initiated: 5 Dec 2018
FDA classified: 30 Mar 2019
Reported: 10 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

5 Dec 2018	Recall initiated by company
30 Mar 2019	Classified by FDA	+115 days
10 Apr 2019	Published in enforcement report	+11 days

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

Reason for recall

When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out.

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

UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the DxC system and the DxI instrument is then connected to an automation line. System Name/ Catalog Number: DxC 660i/ A64871, DxC 680i /A64903, DxC 860i /A64935, DxC 880i /A59102

Where it was distributed

US: NJ, OH, NY, GA, FL, TN, WI, MI, MS, CA, NC, TX, PA, DC, IN, KY, IL, WA, MN, LA, ND, ID, WV, AK, AL, MA. OUS: Argentina, Australia, Bahrain, Canada, China, Croatia, Czech Republic, Egypt, Germany, Greece, India, Italy, Malaysia, Morocco, Netherlands, Nigeria, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Thailand, Tunisia, United Kingdom, United States, Vietnam

Alaska Alabama California District of Columbia Florida Georgia Idaho Illinois Indiana Kentucky Louisiana Massachusetts Michigan Minnesota Mississippi North Carolina North Dakota New Jersey New York Ohio

Questions about this recall

Why was it recalled?

Which lots are affected?

Systems running software versions: 5.2, 5.3.0, 5.3.1.

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 82079

Reported	Class	Recall	Company	Reason	Where
10 Apr 2019	CLASS II	The UniCel DxI 600 and 800 Access Immunoassay Systems recalled	Beckman Coulter	Device Malfunction	26 states

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