SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824.
This recall has been terminated (originally issued May 18, 2006).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- March 30, 2006
- Posted
- May 18, 2006
- Terminated
- February 29, 2012
- Recall Number
- Z-0886-06
- Quantity
- 3147
- Firm Location
- Brea, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide & Canada
Lot / Code Info
Lot numbers M507219 & M511327
Root Cause
Other
Action Taken
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)
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