—#33069

Product

Synchron LX Clinical Systems, Operating Software, All versions.

FDA product code: EXEMP
510(k) numbers: K011213, K014034, K023049, K965240
Affected lot / code info: All Versions.

Why it was recalled

Numeric results are erroneously accepted by the in-house information system without qualifying symbols "<" or ">". In addition, the in-house system may interpret the results incorrectly.

Root cause (FDA determination)

Other

Recalling firm

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

Distribution

Timeline

Recall initiated: 2003-10-10
Posted by FDA: 2004-07-20
Terminated: 2004-07-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #33069. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.