Beckman Coulter Inc Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid).
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Lot M207140
Products Sold
Lot M207140
Beckman Coulter Inc is recalling Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valpro due to Product was found to produce higher recoveries by about 7-12% compared to other lots.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product was found to produce higher recoveries by about 7-12% compared to other lots.
Recommended Action
Per FDA guidance
Users were requested to discard and ask for replacement of the lot in question by letter.
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