Recall Z-0353-04 ยท CEC Radioimmunoassay, Free Thyroxine
Abbott Laboratories HPD/ADD/GPRD
ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064
| Date | Jul 20, 2004 (initiated Dec 15, 2003) |
| Status | Terminated |
| Reason | The calibrator lots may yield Free T4 values that are depressed. |
| Root cause | Other |
| Action | Architect Free T4 Calibrator kits were recalled by letter dated 12/15/03. The accounts were informed of the out of range control values, and the potential for depressed patient values with the kits, and were requested to discontinue use and destroy the affected lots of product. |
| Quantity | 1,364 kits |
| Distribution | Nationwide and internationally to Abbott subsidiaries in Brazil, Canada, Germany, Japan, Singapore, Hong Kong, Thailand, Korea, Australia, Colombia, New Zealand, Venezuela and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983417 | ABBOTT ARCHITECT FREE T4 Abbott Laboratories, Nov 20, 1998 |