Recall Z-2241-2021 ยท JQP Calculator/Data Processing Module, For Clinical Use
Beckman Coulter, Inc.
Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C10575 - Kaluza C Single User 1-year License C10576 - Kaluza C 10 User Network License C10577 - Kaluza C 5 User Network License C10578 - Kaluza C Single Perpetual Educational License C10579 - Kaluza C Single User 1-year Educational License C10580 - Kaluza C 10 User Network Educational
| Date | Jun 23, 2021 |
| Status | Terminated |
| Reason | Software anomalies that may lead to the generation of erroneous results. |
| Root cause | Under Investigation by firm |
| Action | The firm notified its consignees via mail and email on 06/28/2021. Customers were provided with actions to take via customer letter. New customers will be affected by the issue. A stuffer letter will be implemented in new product to notify new customers. New customers downloading Kaluza software from the website will be notified of the issue via email during the downloading process. Product Disposition: A Stop Ship was placed on Kaluza software in order to implement the letter in new kits. |
| Quantity | 1,085 (482 US & 603 OUS) |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV, and Hawaii. The countries of Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, C |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.