The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdinatio
FDA device recall Z-0094-2025 · posted 2024-10-16 · Open, Classified
Recall details
- Recalling firm
- Beckman Coulter, Inc.
- Reason for recall
- Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.
- Action taken
- Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 08/29/2024 via US mail and email. The notice explained the problem, potential impact, requested the discontinuation of use and destruction of the affected product. The notice should be shared with all impacted parties and a retrospective review of patient tests is recommended. For questions regarding this notice, please contact Customer Support Center: . From our website: http://www.beckmancoulter.com . For customers in the United States, if you need replacement product: o Call Client Services at 1-800-854-3633
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- JLW
- Quantity affected
- 2805 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Croatia, France, Germany, Ireland, Italy, Slovakia, Spain, Switzerland, United Kingdom of Great Britain and Northern Irela
- Date initiated
- 2024-08-28
- Date posted
- 2024-10-16
- Location
- Chaska, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer (K221225) | Beckman Coulter, Inc. | 2022-11-10 |