Recall Z-0091-2018
Beckman Coulter Inc. · initiated October 2, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland. The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It is used in conjunction with the following reagents and software package: AQUIOS Tetra-1 Panel monoclonal antibody reagents, AQUIOS Tetra-2+ Panel monoclonal antibody reagents, and AQUIOS CL Flow Cytometry Software.
Codes / lots: All existing software versions (2.0, 2.0.1, and 2.1).
Reason for recall
The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS)
FDA-determined cause: Software design
Action taken
Beckman Coulter sent an Urgent Medical Device Recall letter dated September 28, 2017, and via phone on October 4, 2017. On 11/30/2017, the firm issued an updated letter dated 11/28/2017. The letter informs the customer this letter replaces the instructions in the original notification dated 9/28/2017.
Details
- Recall number
- Z-0091-2018
- Initiated
- October 2, 2017
- Terminated
- May 8, 2019
- Product code
- OYE – Flow Cytometric Reagents And Accessories.
- Quantity
- 268 units
- Distribution
- 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…
- Recalling firm
- Beckman Coulter Inc., Brea, CA