Z-0091-2018 Class II Terminated
FDA device recall Z-0091-2018 was initiated by Beckman Coulter Inc. on October 2, 2017 and is designated Class II. Reason for recall: The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS) The recall status is terminated (terminated May 8, 2019). Affected quantity: 268 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 22, 2017
- Initiation Date
- October 2, 2017
- Termination Date
- May 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 268 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US Distribution to the states of : AZ, CA, CO, FL, GA, IL, IN, KS, NC, NY, OR, PA, SC, TX, and WA, including Puerto Rico and government distribution, and to the countries of : Canada, Angola, Australia, Belgium, Botswana, Brazil, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Kenya, Lesotho, Malawi, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Uganda, Ukraine, United Kingdom, and Zambia.