Beckman Coulter Inc. Recall 88339
Description: Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
Beckman Coulter Inc. Recall 88339 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2332-2021 |
| Event ID | 88339 |
| Event Description | Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of Al, CA, FL, GA, IL, IN, MA, NC, OH, PA, TN, TX and the countries of Australia, Belgium, Canada, China, Czech Republic, France, Italy, Netherlands, New Zealand, Poland, Russia, Switzerland, Taiwan, United Kingdom, United States, Zimbabwe. |
| Quantity | 180 units |
| Recall Reason | There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result. |
| Device Classification | 20210901 |
| Device Code Info | Software Version 2.0 and 2.1 |
| Center Classification Date | 20210823 |
| Recall Initiation Date | 20210715 |
| Recalling Firm | Beckman Coulter Inc. |
| Initial Notification | Letter |
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