Inc Class II Beckman Coulter

Company: Beckman Coulter, Inc
Date of Enforcement Report: 6/23/04
Class: II

PRODUCT
DL 2000 Data Manager. Recall # Z-1027-04.

REASON
Software defect. The type of results affected were replicate type results for a single sample transmitted within the same data stream.

CODE
Version 6.2.

RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letters on February 14, 2003. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
231 units.

DISTRIBUTION
Nationwide.

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