FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels).
- Recall number
- Z-0371-05
- Recalling firm
- Beckman Coulter Inc
- Product
- UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels).
- Status
- Terminated
- Initiated
- 2004-10-29
- Posted
- 2004-12-28
- Terminated
- 2005-03-16
- Reason
- 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
- 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
- 56 boxes
- Distribution
- FL, HI, IL, MS, MI, NC, NY, OH, OK, TX, UT, VA, WI, and Canada
- Lot, serial or model codes
- Part Number: 386167 Lot Number: 04250160
- 510(k) numbers
- ["K023764"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28