Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and Non-Beckman Service Engineers for replacement of worn and/or damaged parts during field services calls.

FDA Recall Z-2687-2014 · Posted 2014-09-23

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2014-08-21
Date Terminated2015-04-30
Product Quantity236 units total (70 units in US)

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

Firm Action

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

Distribution Pattern

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, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121790ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEMBeckman Coulter, Inc. · 2013-09-25K042291UNICEL DXC 600 AND 800 SYNCHRON SYSTEMSBeckman Coulter, Inc. · 2004-11-12K023764UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100Beckman Coulter, Inc. · 2003-01-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑