Terminated

AU480 Chemistry Analyzers, Reference No. B28624 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.

FDA Recall Z-2308-2016 · Posted 2016-08-01

Recalling FirmBeckman Coulter Inc.

Recall StatusTerminated

Product CodeJJE

Date Initiated2015-07-30

Date Terminated2017-02-15

Product Quantity3,355 units total (617 units in US)

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.

Firm Action

In March 2011, the material and molding process of the Coolant cup (C cup) was changed. BEC did not issue a customer notification letter, as we do not believe that a notificationletter was either warranted or of any potential use or value to our customers, because the coolant cup (C cup) is an internal component that only a BEC Field Service Engineer (FSE) can access and inspect i.e., the C cup is not in a customer-accessible part of the analyzer. Thus, there are no specific actions the customer could take to inspect, identify, or mitigate the potential for a crack or leakage of the C cup. For questions regarding this recall call 714-961-4933.

Root Cause

Nonconforming Material/Component

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991743ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (5OShield Gloves Manufacturer (M) Sdn Bhd · 1999-06-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.