FDA Recall Terminated

Synchron LX Clinical Systems, Operating Software, All versions.

Recall: Z-1098-04 · Initiated October 10, 2003

Recall

Recall Number
Z-1098-04
Event Number
29054
Firm
Beckman Coulter Inc
FEI Number
2050012
Product Code
EXEMP
Status
Terminated
Root Cause
Other
Initiated
October 10, 2003
Posted
July 20, 2004
Terminated
July 16, 2004
Address
200 S Kraemer Blvd, Brea, CA, 92822-6208

Description

Synchron LX Clinical Systems, Operating Software, All versions.

Reason

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.

Quantity

816