Company:Beckman Coulter Inc..
Date of Enforcement Report 11/1/2017
Class lI:
PRODUCT
Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.
Recall Number Z-0046-2018
REASON
Beckman Coulter has identified that due to a PLC software nonconformity the 1K Stockyard can initiate a retrieval of a sample tube during the rack loading process, which should not occur. This issue and associated complaint were discovered and filed internally.
RECALLING FIRM/MANUFACTURER
Bedkman Coulter, Brea, CA on 8/3/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
27
DISTRIBUTION
Nationwide China France Italy Kuwait Spain Turkey
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