Recall Z-2108-2016 ยท CDP Radioimmunoassay, Total Triiodothyronine
Beckman Coulter Inc.
Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
| Date | Jun 30, 2016 (initiated Jun 8, 2016) |
| Status | Terminated |
| Reason | Demonstrate an upward shift in patient results. |
| Root cause | Device Design |
| Action | Beckman Coulter sent an " Urgent Medical Device Recall" letter dated June 8, 2016, to all affected customers. Beckman Coulter has determined through customer feedback and internal testing that the Access Free T3 Reagent lots listed above demonstrate an upward shift in patient results. The preliminary results indicate this upward shift may be related to a June 2015 formulation design change that was introduced to improve the Access Free T3 open reagent pack stability. The upward shift in patient test results, therefore, is expected to be maintained for all future lots. The letter informs the c |
| Quantity | 205,744 kits total (13,358 kits in US) |
| Distribution | Worldwide Distribution - US Distribution and to the countries of : Algeria, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Djibouti, Ecuador, Egypt, El Sal |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.