FDA Device recall Z-2332-2021
Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory infor…
- FDA Device
- Class II
- terminated
- Published 2021-09-01
On 2021-09-01 the FDA classified a Class II recall of Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory infor… by Beckman Coulter, citing there is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2332-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-15 |
| Published | 2021-09-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
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.
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.
Identifiers
| code_info | Software Version 2.0 and 2.1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2332-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.