Oxoid Infectious Mononucleosis Test, Catalog #DR0680M. The firm name on the label is Oxoid, Ltd., Basingstoke, Hants, En
FDA device recall Z-0786-06 · posted 2006-04-22 · Terminated
Recall details
- Recalling firm
- Remel, Inc.
- Reason for recall
- Some units exhibit weak false-positive reactions with some negative patient serum
- Action taken
- 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
- Root cause
- Other
- Status
- Terminated
- Product code
- KTN
- Quantity affected
- 27 units
- Distribution
- Nationwide-Distribution was made to a New Jersey distributor.
- Date initiated
- 2006-02-14
- Date posted
- 2006-04-22
- Date terminated
- 2008-03-06
- Location
- Lenexa, KS
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OXOID INFECTIOUS MONONUCLEOSIS KIT (K883540) | Unipath , Ltd. | 1988-10-19 |