—#33159

Product

Synchron LX Clinical Systems Software

510(k) numbers: K011213, K014034, K023049, K965240
Affected lot / code info: All Software versions.

Why it was recalled

'Initial Rate High' parameter for User Defined Reagents does not perform as indicated in the Synchron LX Clinical Systems Operations Manual.

Root cause (FDA determination)

Other

Recalling firm

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

Distribution

Timeline

Recall initiated: 2003-10-07
Posted by FDA: 2004-07-20
Terminated: 2004-08-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #33159. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.