Beckman Coulter Inc
Access 2 Immunoassay System
| Date | Mar 29, 2003 (initiated Jan 30, 2003) |
| Status | Terminated |
| Reason | False results from secondary pour off tubes |
| Root cause | Other |
| Action | Customers with the Access 2 instrument were informed of the recall issue by letter dated 1/30/2003. Those with the LXi 725 were informed by a letter dated 2/5/2003. The letters caution not to use certian Pour off tubes. |
| Quantity | 718 |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K922823 | ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS Bio-Rad Laboratories, Inc., Aug 5, 1992 |