Beckman Coulter Inc UniCel Dxl 800 Access Immunoassay System, P/N 973100. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
UniCel Dxl 800 Access Immunoassay System, P/N 973100.
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
All software versions pior to version 1.4
Products Sold
All software versions pior to version 1.4
Beckman Coulter Inc is recalling UniCel Dxl 800 Access Immunoassay System, P/N 973100. due to Software coding error may cause a fatal error message.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software coding error may cause a fatal error message.
Recommended Action
Per FDA guidance
Each user will be contacted initially and then once more to ensure that the users have recieved the recall letter and have installed the new software included with the letter. Recall letters were sent March 29, 2003.
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