Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Latex slide agglutination test for the differentiation of
FDA device recall Z-1008-2009 · posted 2009-03-20 · Terminated
Recall details
- Recalling firm
- Remel, Inc
- Reason for recall
- Control and test wells are reversed on some of the reaction cards.
- Action taken
- The recalling firm issued Important Medical Device Customer Advisory Notice letters dated 10/7/08 via regular mail to their customers explaining the reason for recall. The letter requested that they review their inventory for the product lots indicated in the letter; discard all of the lot remaining in their inventory; complete and return the Product Inventory Checklist.
- Root cause
- Pending
- Status
- Terminated
- Product code
- JWX
- Quantity affected
- 32 kits dist. by recalling firm
- Distribution
- Nationwide Distribution -- including MN, MI, IL, and NC.
- Date initiated
- 2008-10-07
- Date posted
- 2009-03-20
- Date terminated
- 2009-07-30
- 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 |
|---|---|---|
| STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS (K972030) | Oxoid , Ltd. | 1997-09-08 |