Recall Z-0110-2016 ยท CDP Radioimmunoassay, Total Triiodothyronine
Beckman Coulter Inc.
Access Free T3 Reagent Kit, P/N 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 | Oct 7, 2015 (initiated Aug 31, 2015) |
| Status | Terminated |
| Reason | Beckman Coulter, Inc. is recalling Access Free T3 Reagent Kit because they were filled incorrectly and contain insufficient quantity of reagents in one or more of the pack wells. |
| Root cause | Under Investigation by firm |
| Action | Beckman Coulter sent an " Urgent Medical Device Recall" letter dated August 31, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informs the customers that some Access Free T3 reagent packs (p/n A13422) of lot 431433 were filled incorrectly and contain insufficient quantity of reagents in one or more of the pack wells. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with any questions regarding the notice are instructed to contact Customer Supp |
| Quantity | 16,648 units total (1874 units in US) |
| Distribution | Worldwide Distribution - US (nationwide) and to the countries of : Australia, Brazil, Canada, China, Colombia, Costa Rica, Hong Kong, Israel, Japan, Kuwait, Macao, Malaysia, Mexico, New Zealand, Saudi Arabia, Singapore, Taiwan, Thailand and Viet Nam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960913 | ACCESS FREE T3 ASSAY Bio-Rad Laboratories, Inc., Mar 29, 1996 |