Company: Beckman Coulter Inc.,
Date of Enforcement Report:5/31/2006
Class:lIl

PRODUCT
a) SYNCHRON LX 20, SYNCHRON LX 20 PROClinical Systems; Operating Software
Version 4.5; Part Number: A23724 In vitro diagnostic, Recall # Z-0900-06;
b) SYNCHRON LX i 725 Clinical Systems; Operating Software Version 4.5; Part
Number: A23724, Recall # Z-0901-06;
c) Unicel DxC 600/800 SYNCHRON Clinical Systems; Operating Software Version 1.0 and 1.2; Part Number: A20463 and A27331, Recall # Z-0902-06

REASON
It was confirmed that the ORDAC (Over Range Detection And Correction) feature (auto & manual) does not perform correctly for the glucose cup chemistry (GLUCm) when sample type of ‘Other’ is selected w/operating software version 4.5. Results for these samples could be elevated as much as twice the actual value. The ORDAC feature does function properly w/serum, plasma, urine & CSF.

CODE
a) Operating Software Version 4.5;
b) Software Version 4.5;
c) Software Version 1.0 and 1.2

RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc, Fullerton, CA, by letter the week of March 15, 2006.
Manufacturer: Beckman Coulter, Inc., Brea, CA. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2,800 systems total

DISTRIBUTION
Nationwide and Internationally