Z-0371-05

UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels)

Name: Z-0371-05 UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels)
Creator: Beckman Coulter Inc
Published: 2004-10-29
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-10-29 / Terminated / root cause: packaging

FDA source

Beckman Coulter Inc began a recall of UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels) on 2004-10-29. The reason FDA records is "Beckman Coulter has confirmed reports of rare occurrences of UniCel Dxl 800 Access Immunoassay Systems Reaction Vessels that are deformed or flattened in their packaging bags for lot 04250160. Deformed or flattened RVs...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0371-05
Status: Terminated
Initiated: 2004-10-29
Posted: 2004-12-28
Terminated: 2005-03-16
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels).
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Beckman Coulter has confirmed reports of rare occurrences of UniCel Dxl 800 Access Immunoassay Systems Reaction Vessels that are deformed or flattened in their packaging bags for lot 04250160. Deformed or flattened RVs could present a rish of causing jams on the UniCel Exl 800 Access Immunoassay Systems that may require service intervention and could compromise sample analysis.
Root cause tag: packaging
FDA root cause: Other
Action: All customers that were shipped lot 042500160 of the reaction vessels were contacted via telephone (or via on-site visit - Canada only) October 29 - November 1, 2004. A Product Correction Action Letter dated November 2,2 004, sent via U.S. mail to all customers, once contacted by phone with fax back forms.
Quantity in commerce: 56 boxes
Distribution: FL, HI, IL, MS, MI, NC, NY, OH, OK, TX, UT, VA, WI, and Canada
Product codes and lots: Part Number: 386167 Lot Number: 04250160

Product code JJE

K023764Class IUnicel Dxi 800 Access Immunoassay System, Model 973100Beckman Coulter, Inc. / cleared 2003-01-28

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)