Recall Z-0786-06 ยท KTN System, Test, Infectious Mononucleosis
Remel, Inc.
Oxoid Infectious Mononucleosis Test, Catalog #DR0680M. The firm name on the label is Oxoid, Ltd., Basingstoke, Hants, England
| Date | Apr 22, 2006 (initiated Feb 14, 2006) |
| Status | Terminated |
| Reason | Some units exhibit weak false-positive reactions with some negative patient serum |
| Root cause | Other |
| Action | The recalling firm issued a letter dated 2/14/06 to their only customer requesting the product be destroyed. The distributor was audited by FDA to assure subrecall |
| Quantity | 27 units |
| Distribution | Nationwide-Distribution was made to a New Jersey distributor. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K883540 | OXOID INFECTIOUS MONONUCLEOSIS KIT Unipath , Ltd., Oct 19, 1988 |