Recalls / —

—#34379

Product

SYNCHRON Clinical Systems Enzyme Validator Kit

FDA product code

JIX — Calibrator, Multi-Analyte Mixture

Device class

Class 2

Medical specialty

Clinical Chemistry

510(k) numbers

K984014

Affected lot / code info

M310400

Why it was recalled

incorrect Calibration Acceptance Limits.

Root cause (FDA determination)

Other

Action the firm took

Recall letter sent 07/29/2004, informing customers to discard all calibration diskettes and load a new calibration diskette.

Recalling firm

Firm

Beckman Coulter Inc

Address

200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern

Nationwide & Canada

Timeline

Recall initiated

2004-07-29

Posted by FDA

2004-08-17

Terminated

2005-02-03

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #34379. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.