31

May

2006

Class IIl Beckman Coulter Inc

0

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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