FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: Access Immunoassay Systems Thyroglobulin Antibody Reagent Kit, Part Number 33890
- Recall number
- Z-0417-2007
- Recalling firm
- Beckman Coulter Inc
- Product
- Access Immunoassay Systems Thyroglobulin Antibody Reagent Kit, Part Number 33890
- Status
- Terminated
- Initiated
- 2006-10-26
- Posted
- 2007-02-07
- Terminated
- 2012-04-30
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 474 units
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- 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)
- 510(k) numbers
- ["K012208"]
- PMA numbers
- not on file
- Product code
- DDC
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28