Recall Z-1026-2007 ยท LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Abbott Laboratories
AxSYM CA 125 Reagent Pack; list 03B41; 100 test pack; an in vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064
| Date | Jul 11, 2007 (initiated Apr 23, 2007) |
| Status | Terminated |
| Reason | Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument. |
| Root cause | Other |
| Action | Abbott initiated a field correction recall by letter dated 4/23/07 to all customers receiving the affected reagents. The accounts were informed of the failure of the AxSYM to open (actuate) some reagent packs with the affected lots. The accounts were requested to inspect each reagent pack for broken or improperly sealed caps; manually open each bottle to ensure the flipper bar raises the reagent cap correctly; close each flipper bar prior to loading the reagent pack on the instrument; and discard any reagent packs that do not open properly. If the user observes a probe crash, prior to testing |
| Quantity | 911 packs |
| Distribution | Worldwide, including USA, Puerto Rico, Argentina, Australia, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Hong Kong, Mexico, New Zealand, Singapore, South Korea, Taiwan, Thailand and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964020 | AXSYM CA 125 Abbott Laboratories, Nov 4, 1997 |