—#94447

Product

Access Immunoassay Systems, Part Number: 81600 ; Access 2 Immunoassay Systems, Part Number: 81600N; Synchron LXi 725; UniCel DxI 800 Access Immunoassay Systems, Part Number: 973100; UniCel DxI 600 Access Immunoassay Systems, Part Number A30260; UniCel DxC 600i, Part Number: A25656; UniCel DxC 660i, Part Number: A64871; UniCel DxC 860i, Part Number: A64935; UniCel DxC 880i, Part Number: A59102; SYNCHRON Access Clinical Systems The Access/DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration found in human body fluids. Function of the Peristaltic Pump: to aspirate unbound material from reaction vessels and to move waste from vacuum jar into waste bottle through associated tubing within the Access Immunoassay System.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K023764, K060256, K922823
Affected lot / code info: All versions are affected.

Why it was recalled

This recall was initiated because Beckman Coulter has received reports of erroneous test results being reported as a result of assay reagent packs being transferred between systems. Erroneous results will be generated as a result of missing or incorrect assay reagents. In these cases both false positive and false negative results are possible, depending upon the assay configuration.

Root cause (FDA determination)

Pending

Action the firm took

Beckman Coulter, Inc. sent two (2) Product Corrective Action (PCA) letters (Access letter and DxI letter) with attached Customer Response form the week of August 09, 2010 to the affected customers. The letters were dated August 13, 2010, and identified the product, the problem, and the action to be taken by the customers. The letter reminded customers that it is critical that they load reagent packs according to the procedure provided in their Access or Access 2 Operators Guide, Instructions for Use, or Help system. A copy of the procedure was included with the letter. Customers were reminded that all operators should be properly trained on these important procedures and understand the impact on reported results if these procedures are not followed. Customers were instructed to share this information with their laboratory staff, and retain this notification as part of their laboratory Quality System documentation. Customers who needed assistance or had any questions regarding this notification, were instructed to contact Technical Support at 1-800-854-3633, option 1 in the United States or Canada.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

Distribution pattern: Nationwide Distribution & Canada

Timeline

Recall initiated: 2010-08-13
Posted by FDA: 2010-12-13
Terminated: 2012-07-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94447. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.