Recalls / —

—#32781

Product

Synchron Systems Acetaminophen Reagent, part No. 472169.

FDA product code

LDP — Colorimetry, Acetaminophen

Device class

Class 2

Medical specialty

Clinical Toxicology

Affected lot / code info

All lots

Why it was recalled

Firm shortened calibration frequency to 7 days from 14 days.

Root cause (FDA determination)

Other

Action the firm took

Firm issued letters to customers indicating need to shorten the calibration period from 14 to 7 days.

Recalling firm

Firm

Beckman Coulter Inc

Address

200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern

Nationwide and Canada

Timeline

Recall initiated

2003-09-04

Posted by FDA

2004-07-20

Terminated

2005-01-04

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #32781. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.