Recalls / —

—#32782

Product

Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid).

FDA product code

KLT — Enzyme Immunoassay, Carbamazepine

Device class

Class 2

Medical specialty

Clinical Toxicology

510(k) numbers

K955644

Affected lot / code info

Lot M207140

Why it was recalled

Product was found to produce higher recoveries by about 7-12% compared to other lots.

Root cause (FDA determination)

Other

Action the firm took

Users were requested to discard and ask for replacement of the lot in question by letter.

Recalling firm

Firm

Beckman Coulter Inc

Address

200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern

Nationwide and Canada

Timeline

Recall initiated

2003-06-11

Posted by FDA

2004-07-20

Terminated

2004-05-10

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #32782. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.