CLASS II Device recall · Reported 31 May 2017 · FDA Enforcement Report

UniCel DxH 600 Coulter Cellular Analysis System recalled

Beckman Coulter is recalling UniCel DxH 600 Coulter Cellular Analysis System, distributed nationwide in the US. The recall was initiated on 24 Apr 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesall software versions

Quantity recalled1408 units total (998 units in US)

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-2158-2017
FDA event ID: 77145
Recalling firm: Beckman Coulter, Brea, CA
Classification: Class II
Status: Terminated
Recall initiated: 24 Apr 2017
FDA classified: 24 May 2017
Reported: 31 May 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

24 Apr 2017	Recall initiated by company
24 May 2017	Classified by FDA	+30 days
31 May 2017	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

There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result.

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 DxH 600 Coulter Cellular Analysis System, Catalog No. B23858.

Where it was distributed

Worldwide distribution: US nationwide, Algeria, Andorra, Austria, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Cote d'lvoire, Croatia, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan , Kuwait, Lebanon, Lithuania ,Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania , Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia , South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, Uruguay and Vietnam.

Nationwide Puerto Rico

Questions about this recall

Is UniCel DxH 600 Coulter Cellular Analysis System recalled?

Yes. Beckman Coulter recalled UniCel DxH 600 Coulter Cellular Analysis System on 24 Apr 2017. The recall is Class II and its status is Terminated. Recall number Z-2158-2017.

Why was it recalled?

Which lots are affected?

all software versions

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

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