Beckman Coulter Inc UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels).
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Part Number: 386167 Lot Number: 04250160
Products Sold
Part Number: 386167 Lot Number: 04250160
Beckman Coulter Inc is recalling UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels). due to Beckman Coulter has confirmed reports of rare occurrences of UniCel Dxl 800 Access Immunoassay Systems Reaction Vessels that are deformed or flattened. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, HI, IL, MI, MS, NY, NC, OH, OK, TX, UT, VA, WI
Page updated: Jan 10, 2026