Recall Z-0886-06 ยท LEH Radioimmunoassay, Vancomycin
Beckman Coulter Inc
SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824.
| Date | May 18, 2006 (initiated Mar 30, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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) |
| Quantity | 3147 |
| Distribution | Nationwide & Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013076 | SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR Beckman Coulter, Inc., Dec 12, 2001 |