—#45675

Product

SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824.

FDA product code: LEH — Radioimmunoassay, Vancomycin
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K013076
Affected lot / code info: Lot numbers M507219 & M511327

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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)

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern: Nationwide & Canada

Timeline

Recall initiated: 2006-03-30
Posted by FDA: 2006-05-18
Terminated: 2012-02-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #45675. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.