Z-0607-2011

Access Immunoassay Systems, Part Number: 81600 ; Access 2 Immunoassay Systems, Part Number: 81600N; Synchron...

Name: Z-0607-2011 Access Immunoassay Systems, Part Number: 81600 ; Access 2 Immunoassay Systems, Part Number: 81600N; Synchron...
Creator: Beckman Coulter Inc.
Published: 2010-08-13
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-08-13 / Terminated

FDA source

Beckman Coulter Inc. began a recall of Access Immunoassay Systems, Part Number: 81600 ; Access 2 Immunoassay Systems, Part Number: 81600N; Synchron LXi 725; UniCel DxI 800 Access Immunoassay... on 2010-08-13. The reason FDA records is "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 of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0607-2011
Status: Terminated
Initiated: 2010-08-13
Posted: 2010-12-13
Terminated: 2012-07-11
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: 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.
FDA root cause: Pending
Action: 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.
Quantity in commerce: 9571 units (instruments)
Distribution: Nationwide Distribution & Canada
Product codes and lots: All versions are affected.

Product code JJE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)