Medical device recalls Moderate risk

Beckman Coulter Inc. recalls Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.

Recall date
August 3, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0046-2018
FDA classification
Class II
Brand / firm
Beckman Coulter Inc.
Sold / distributed
China France Italy Kuwait Spain Turkey United States

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.

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