Beckman Coulter Inc SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824.
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Lot numbers M507219 & M511327
Products Sold
Lot numbers M507219 & M511327
Beckman Coulter Inc is recalling SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824. due to Beckman Coulter has received reports of patient samples and quality control recovery shifting low when using Vancomycin reagent lots M507219 and M5113. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Beckman Coulter has received reports of patient samples and quality control recovery shifting low when using Vancomycin reagent lots M507219 and M511327. Internal QC recovery was as much as 15% lower than the assigned target value.
Recommended Action
Per FDA guidance
A Product Corrective Action (PCA) letter was be sent the week of MAR 30, 2006 to all SYNCHRON Systems Vancomycin Reagent customers of lot numbers M507219 and M511327 informing them to discontinue use and discard reagent. (Letters were sent by US mail)
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