Beckman Coulter Inc UniCel Dxl Access Immunoassay Systems Reaction Vessels for Use with UniCel Dxl Access Immunoassay Systems, Part Number : 386167, Beckman Coulter, Inc, Brea CA 92822 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Part Number: 386167, Lot Code: 1201291 & 1201431
Products Sold
Part Number: 386167; Lot Code: 1201291 & 1201431
Beckman Coulter Inc is recalling UniCel Dxl Access Immunoassay Systems Reaction Vessels for Use with UniCel Dxl Access Immunoassay Sy due to Erroneous Results - UniCel Dxl Access Immunoassay Systems Reaction Vessels have been found to be defective and there is a potential for an increase in. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026