Beckman Coulter Inc DL 2000 Data Manager Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DL 2000 Data Manager
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Not Applicable but refers to software version 6.4.109f
Products Sold
Not Applicable but refers to software version 6.4.109f
Beckman Coulter Inc is recalling DL 2000 Data Manager due to Version v6.4.109f, any result designated as 'calculated chemistry' at DL2000 may upload to the LIS with an incorrect or blank sample ID.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Version v6.4.109f, any result designated as 'calculated chemistry' at DL2000 may upload to the LIS with an incorrect or blank sample ID.
Recommended Action
Per FDA guidance
Recall letters were sent during the week of June 20, 2005. It explains the problem and indicates that an enclosed software correction must be installed to correct the problem.
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