Recalls / —
—#67282
Product
UniCel Dxl Access Immunoassay Systems Reaction Vessels for Use with UniCel Dxl Access Immunoassay Systems, Part Number : 386167, Beckman Coulter, Inc, Brea CA 92822
- FDA product code
- MMI — Immunoassay Method, Troponin Subunit
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K023764
- Affected lot / code info
- Part Number: 386167; Lot Code: 1201291 & 1201431
Why it was recalled
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.
Root cause (FDA determination)
Process design
Action the firm took
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.
Recalling firm
- Firm
- Beckman Coulter Inc
- Address
- 200 S Kraemer Blvd, Brea, California 92822-6208
Distribution
- Distribution pattern
- Nationwide & Canada
Timeline
- Recall initiated
- 2007-07-19
- Posted by FDA
- 2008-03-19
- Terminated
- 2012-05-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #67282. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.