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Recall Observatory FDA recall evidence

Device product

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.

Z-2310-2016

July 30, 2015

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 74568
Status
Terminated
Classification
Class II
Quantity
2,130 units total (588 units in US)
Official record key
device-enforcement:Z-2310-2016

Official wording

Reason: 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.

Code information: 1040016

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.