Beckman Coulter Inc DataLink 2000 Data Manager Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DataLink 2000 Data Manager
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Version 6.3
Products Sold
Version 6.3
Beckman Coulter Inc is recalling DataLink 2000 Data Manager due to Software anomaly allows results to be archived prior to validation or to be uploaded to the lab information system.. Based on FDA medical device recall database.
Summary derived from FDA notice
The following details were not provided by the FDA: distribution information, corrective action details.
Reason for Recall
As stated by FDA
Software anomaly allows results to be archived prior to validation or to be uploaded to the lab information system.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026