Access Immunoassay Systems Thyroglobulin Antibody Reagent Kit, Part Number 33890
This recall has been terminated (originally issued February 7, 2007).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- October 26, 2006
- Posted
- February 7, 2007
- Terminated
- April 30, 2012
- Recall Number
- Z-0417-2007
- Quantity
- 474 units
- Firm Location
- Brea, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Low end imprecision affecting both S0 calibrators and patient samples which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay.
Distribution
Nationwide and Canada
Lot / Code Info
518729 (expires 10/31/06); 520617 (expires 12/31/06); 612764 (expires 12/31/06); 613481 (expires 3/31/07); 614541 (expires 5/31/07); 616787 (expires 8/31/07)
Root Cause
Other
Action Taken
A Product Corrective Action (PCA) letter was mailed on Oct 27, 2006 to all Thyroglobulin Antibody customers. They are informed that there has been an increase in customer feedback regarding low end imprecision affecting both S0 calibrators and patient samples, which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay. The letter informs the customer that the firm recommends that they use an alternate method for testing TgAb. (Letter was sent by US mail). Customers are asked to complete and return the enclosed response form within 10 days.