Beckman Coulter Access Thyroglobulin Antibody II Reagent, Part Number: A32898. The Access Thyroglobulin Antibody II (TgA
FDA device recall Z-2355-2010 · posted 2010-09-02 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- The affected Access Thyroglobulin Antibody II reagent may produce inaccurate results due to a change in the thyroglobulin that was used in the kits.
- Action taken
- Beckman Coulter sent an "Urgent Product Corrective Action" letter dated June 29, 2010, with attached Customer Response form to the affected customers. The letter identified the affected product and issue. Customers were instructed to: (1) Discontinue use of Access Thyroglobulin Antibody II reagent lot numbers 916271, 917073, and 918433. (2) Review results in the context of the total clinical presentation of the patient, and rerun questionable results using another reagent. (3) Complete and return a response form within 10 days. (4) For replacement contact Beckman Coulter at (US) 1-800-526-3821, (Canada) 1-800-463-7828. Customer Technical Support can be contacted at 1-800-854- 3633.
- Root cause
- Other
- Status
- Terminated
- Product code
- JNL
- Quantity affected
- 1071 units
- Distribution
- Worldwide distribution : United States, including states of CA, CO, FL, GA. IA, IL, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI, and country of Canada.
- Date initiated
- 2010-06-29
- Date posted
- 2010-09-02
- Date terminated
- 2012-05-04
- 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 II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) (K062516) | Beckman Coulter, Inc. | 2006-10-05 |