Recall Z-1341-2018
Beckman Coulter Inc. · initiated January 29, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland.
Codes / lots: All software versions.
Reason for recall
The device may process the same sample with two different sample IDs and sample information while using the single tube loader, which has the potential for erroneous results due to the mis-identification.
FDA-determined cause: Software design
Action taken
The recalling firm issued letters dated 1/25/2018 via email on 1/31/2018 or to some customers via regular mail during the week of 1/29/2018.
Details
- Recall number
- Z-1341-2018
- Initiated
- January 29, 2018
- Terminated
- June 27, 2019
- Product code
- OYE – Flow Cytometric Reagents And Accessories.
- Quantity
- 288 devices
- Distribution
- Distribution was made nationwide in the U.S. and in Puerto Rico. There was also government distribution, but no military distribution. Foreign distribution was made to Angola, Australia, Belgium, Botswana, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Japan, Kazakhstan, Kenya, Lesotho, Malawi, Malaysia, Mexico…
- Recalling firm
- Beckman Coulter Inc., Brea, CA