—#35798

Product

UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels).

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K023764
Affected lot / code info: Part Number: 386167 Lot Number: 04250160

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

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

Timeline

Recall initiated: 2004-10-29
Posted by FDA: 2004-12-28
Terminated: 2005-03-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #35798. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.