Medical DevicesNationwide
Beckman Coulter Inc SYNCHRON Clinical Systems Enzyme Validator Kit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SYNCHRON Clinical Systems Enzyme Validator Kit
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
M310400
Products Sold
M310400
Beckman Coulter Inc is recalling SYNCHRON Clinical Systems Enzyme Validator Kit due to incorrect Calibration Acceptance Limits.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
incorrect Calibration Acceptance Limits.
Recommended Action
Per FDA guidance
Recall letter sent 07/29/2004, informing customers to discard all calibration diskettes and load a new calibration diskette.
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