Recall Z-0046-2018— Beckman Coulter Inc.

Name: FDA recall Z-0046-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-03

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2017-08-03, terminated 2023-09-27. It names one FDA 510(k) clearance: K110413. Product: Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.. 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: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-08-03
Terminated: 2023-09-27
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K110413 — POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONSBeckman Coulter, Inc.·cleared 2011-05-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.