Recall Z-0094-2025 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Beckman Coulter, Inc.
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. This
| Date | Oct 16, 2024 (initiated Aug 28, 2024) |
| Status | Open, Classified |
| Reason | Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results. |
| Root cause | Under Investigation by firm |
| Action | 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 1-800-854-3 |
| Quantity | 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 Ireland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221225 | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer Beckman Coulter, Inc., Nov 10, 2022 |