CLASS II Device recall · Reported 10 Aug 2016 · FDA Enforcement Report

AU5800 Chemistry Analyzers, Reference No. A98352 The AU recalled

Beckman Coulter is recalling AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated, clinical, distributed nationwide in the US. The recall was initiated on 30 Jul 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1040016

Quantity recalled2,130 units total (588 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-2310-2016
FDA event ID: 74568
Recalling firm: Beckman Coulter, Brea, CA
Classification: Class II
Status: Terminated
Recall initiated: 30 Jul 2015
FDA classified: 1 Aug 2016
Reported: 10 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Test Kits & Diagnostics

Timeline

30 Jul 2015	Recall initiated by company
1 Aug 2016	Classified by FDA	+368 days
10 Aug 2016	Published in enforcement report	+9 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 received complaints regarding leaking and cracked C cups. When the cup cracks, coolant can leak onto the connectors of the Printed Circuit Boards (PCB) in the analyzer, resulting in a short-circuit causing the instrument to go into a stop mode.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories.

Where it was distributed

Worldwide Distribution - US (nationwide (including Guam and Puerto Rico), and Internationally to Albania, Algeria, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Liberia, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States Uruguay, Viet Nam, Zambia, Zimbabwe.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

1040016

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

2 other products · FDA event 74568

This product is part of a recall event; the main page for the event is AU680 Chemistry Analyzers, Reference No. B04779 The AU recalled.

Reported	Class	Recall	Company	Reason	Where
10 Aug 2016	CLASS II	AU680 Chemistry Analyzers, Reference No. B04779 The AU recalled	Beckman Coulter	Packaging Defects	Nationwide
10 Aug 2016	CLASS II	AU480 Chemistry Analyzers, Reference No. B28624 The AU recalled	Beckman Coulter	Packaging Defects	Nationwide

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