Access Immunoassay Systems Thyroglobulin Antibody Reagent Kit, Part Number 33890
FDA device recall Z-0417-2007 · posted 2007-02-07 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DDC
- Quantity affected
- 474 units
- Distribution
- Nationwide and Canada
- Date initiated
- 2006-10-26
- Date posted
- 2007-02-07
- Date terminated
- 2012-04-30
- 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 |
|---|---|---|
| ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895 (K012208) | Beckman Coulter, Inc. | 2001-09-07 |