UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- October 29, 2004
- Posted
- December 28, 2004
- Terminated
- March 16, 2005
- Recall Number
- Z-0371-05
- Quantity
- 56 boxes
- Firm Location
- Brea, CA
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.
Distribution
FL, HI, IL, MS, MI, NC, NY, OH, OK, TX, UT, VA, WI, and Canada
Lot / Code Info
Part Number: 386167 Lot Number: 04250160
Root Cause
Other
Action Taken
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.