Company: Beckman Coulter Inc
Date of Enforcement Report 5/28/2008
Class:ll
PRODUCT
a) Synchron LX20 Clinical Chemistry System, Part Numbers: 466200,473032,
Recall # Z-1094-2008;
b) Synchron LX20 PRO, Part Number 476100, Recall # Z-1095-2008;
c) Synchron LXi 725, Part Number A08357, Recall # Z-1096-2008;
d) UniCel DxC 600 Part Number: A10405, Recall # Z-1097-2008;
e) UniCel DxC 600i, Part Numbers: A25638, A25639, Recall # Z-1098-2008;
f) UniCel DxC 600 PRO Part Number: A10400, Recall # Z-1099-2008;
g) UniCel DxC 800 Part Number: A10411, Recall # Z-1100-2008;
h) UniCel DxC 800 PRO Part Number: A10407, Recall # Z-1101-2008
REASON
Intermittent Failure of Stirrer Motor-Beckman Coulter has determined that incorrect Glucose results on LX20 or DxC instruments have been related to an intermittent failure of the stirrer motor. -Stirrer motors can stall without any flags or motion errors. -If a stall occurs during a GLUm test near the time of sample inject, results may be affected. -Affected GLUm results may be high or low.
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc, Brea, CA, decided that Customer Notification is not needed. Replacements began April 5, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2,599 units
DISTRIBUTION
Nationwide and Internationally
