Beckman Coulter Inc Synchron Systems Lipid Calibrator (HDLD) Part 650218 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Synchron Systems Lipid Calibrator (HDLD) Part 650218
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Kit, M302210 Level 1, M302211 Level 2, M302212
Products Sold
Kit; M302210 Level 1; M302211 Level 2; M302212
Beckman Coulter Inc is recalling Synchron Systems Lipid Calibrator (HDLD) Part 650218 due to Incorrect units are printed in labeling but not in software.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect units are printed in labeling but not in software.
Recommended Action
Per FDA guidance
Letter was mailed which explains tha the units on the Value Sheet are printed incorrectly. Recall is complete.
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