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Terminated

UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels).

FDA Recall Z-0371-05 · Posted 2004-12-28

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2004-10-29
Date Terminated2005-03-16
Product Quantity56 boxes

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.

Firm 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.

Root Cause

Other

Distribution Pattern

FL, HI, IL, MS, MI, NC, NY, OH, OK, TX, UT, VA, WI, and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023764UNICEL 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.

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