UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels).
FDA device recall Z-0371-05 · posted 2004-12-28 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 56 boxes
- Distribution
- FL, HI, IL, MS, MI, NC, NY, OH, OK, TX, UT, VA, WI, and Canada
- Date initiated
- 2004-10-29
- Date posted
- 2004-12-28
- Date terminated
- 2005-03-16
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 (K023764) | Beckman Coulter, Inc. | 2003-01-28 |