Recall Z-1132-03 ยท CEC Radioimmunoassay, Free Thyroxine
Abbott Laboratories HPD/ADD
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 | Aug 13, 2003 (initiated May 30, 2003) |
| Status | Terminated |
| Reason | The Free T4 Controls, may yield control values that are high and outside of the package insert ranges. |
| Root cause | Other |
| Action | The Free T4 Control Pack, list 9C03-10, and the IMx Free T4 Reagent Kit, list 2222-20, were recalled by letter dated 5/30/03. The accounts were informed of the out of range control values, and the potential for depressed patient values with the IMx kit, and were requested to discontinue use and destroy the affected lots of product. Abbott sent a Device Correction letter dated 6/4/03 to those accounts receiving the Architect Free T4 Calibrator kits, informing them of the problems experienced with the The Free T4 Control Pack, list 9C03-10, and the IMx Free T4 Reagent Kit, list 2222-20, made f |
| Quantity | 330 kits |
| Distribution | Nationwide and internationally to Abbott subsidiaries in Ecuador, Uruguay, Argentina, Brazil, El Salvador, Canada, Germany, Japan, Singapore, Hong Kong, Thailand, Korea, Australia, Costa Rica, Grenada, St. Lucia, Bermuda, Antigua, Panama, Guatemala, Mexico, Colombia, Jamaica, Paraguay, Peru, Chile, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983417 | ABBOTT ARCHITECT FREE T4 Abbott Laboratories, Nov 20, 1998 |