—#33129

Product

Synchron Liquid Comprehensive Chemistry Control Serum. Part numbers: 660710, 657365.

FDA product code: LEH — Radioimmunoassay, Vancomycin
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K013235
Affected lot / code info: Lots: M202040, M206290

Why it was recalled

The quality control samples for Vancomycin would not recover correctly when compared to the S.I. unit values listed in the incorrectly printed product insert. The incorrectly printed values were higher than they should be by a factor of 3 (three).

Root cause (FDA determination)

Other

Recalling firm

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

Distribution

Timeline

Recall initiated: 2003-04-01
Posted by FDA: 2004-07-23
Terminated: 2004-08-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #33129. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.