UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative,

FDA device recall Z-2687-2014 · posted 2014-09-23 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

Beckman Coulter is recalling the Sample Probe Cable because nonconforming sample probe cables may been installed on newly manufactured and/or recently serviced UniCel DxI 600 and 800 Access Immunoassay Systems, UniCel DxC 660i, 680i, and 860i, and UniCel DxC 880i Synchron Access Clinical Systems instruments. Use of a nonconforming sample probe cable can casuse a delay in reporting results, but wi

Action taken

A customer notification letter dated 8/21/14 was sent to all customers who purchased the Sample Probe Cable for use with the UniCel DxI Family of Immunoassay Systems. The letter informs the customers of the problems identified and the actions to be taken. Customer are instructed to complete and return the enclosed response form within 10 days. Customers are instructed to call (800) 854-3633 in US and Canada.

Root cause

Under Investigation by firm

Status

Terminated

Product code

JJE

Quantity affected

236 units total (70 units in US)

Distribution

Nationwide in US and worldwide: Canada, China, Colombia, Croatia, Czech Republic, France, Germany, India, Italy, Japan, Korea, Kuwait, Malaysia, Mexico, Philippines, Puerto Rico, Russia, Singapore, Sl

Date initiated

2014-08-21

Date posted

2014-09-23

Date terminated

2015-04-30

Location

Brea, CA

Related 510(k) clearances