UniCel Dxl Access Immunoassay Systems Reaction Vessels for Use with UniCel Dxl Access Immunoassay Systems, Part Number :
FDA device recall Z-1108-2008 · posted 2008-03-19 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Erroneous Results - UniCel Dxl Access Immunoassay Systems Reaction Vessels have been found to be defective and there is a potential for an increase in signal leading to an erroneous result.
- Action taken
- A Product Corrective Action (PCA) letter was mailed on July 19, 2007, to the Customers that received UniCel Dxl Access lmmunoassay System Reaction Vessels lot 1201291 and 1201431. The customers were informed that a small percentage of the reaction vessels (Lot #s: 1201291and 1201431 ) have been found to be defective and there is a potential for an increase in signal leading to an erroneous result. The customers were instructed to discontinue use and discard these lots. A response form was included.
- Root cause
- Process design
- Status
- Terminated
- Product code
- MMI
- Quantity affected
- 264 units in the US; 9 units in Canada
- Distribution
- Nationwide & Canada
- Date initiated
- 2007-07-19
- Date posted
- 2008-03-19
- Date terminated
- 2012-05-04
- 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 |