Recall Z-0541-05 ยท LHL Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
Diamedix Corporation
The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert.
| Date | Feb 15, 2005 (initiated Dec 23, 2004) |
| Status | Terminated |
| Reason | The kits belonging to lot #s 30804/30804Z and 91803Z may lose activity, after one or two usages, causing the OD values for the Cut-Off Calibrator and/or Positive Control to be recovered below their specified ranges. |
| Root cause | Other |
| Action | Direct customers were notified by letter on 12/23/2004 by Federal Express.100% of the total customers will be contacted. The letter instructed the consignees to discontinue use immediately and arrange to return the product to Diamedix. |
| Quantity | 178 |
| Distribution | Distributed to Domestic customers only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970149 | LEGIONELLA ELISA TEST SYSTEM Zeus Scientific, Inc., Jun 18, 1997 |