FDA recall Z-0046-2018

Product

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

Reason for recall

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.

Distribution

China France Italy Kuwait Spain Turkey United States

Key facts

Status

Terminated

Initiation date

2017-08-03

Report date

2017-11-01

Termination date

2023-09-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brea, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0046-2018