AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is
FDA device recall Z-2035-2017 · posted 2017-04-17 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS System software is not correctly exporting Tetra Combo CRD files.
- Action taken
- An Urgent Medical Device Recall letter was sent on 4/3/17 to inform customers that area of the AQUIOS System software is not correctly exporting Tetra Combo CRD files. The letter informs the customers of the impact, action, and resolution. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to contact Customer Support Center via website, http://www.beckmancoulter.com/customersupport/support, Via phone, call 1-800-369-0333 in the US. Customers outside the US are instructed to contact their local Beckman Coulter Representative.
- Root cause
- Other
- Status
- Terminated
- Product code
- OYE
- Quantity affected
- 188 units total (24 units in US)
- Distribution
- Worldwide - US Nationwide in the countries of: Angola, Australia, Belgium, Botswana, Canada, Chile, Columbia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Israel, Italy, Malaysia, Nambia,
- Date initiated
- 2017-04-03
- Date posted
- 2017-04-17
- Date terminated
- 2017-08-07
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS (K141932) | Beckman Coulter, Inc. | 2015-04-10 |