Recall Z-1008-2009 ยท JWX Kit, Screening, Staphylococcus Aureus
Remel, Inc
Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Latex slide agglutination test for the differentiation of Staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccharides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties.
| Date | Mar 20, 2009 (initiated Oct 7, 2008) |
| Status | Terminated |
| Reason | Control and test wells are reversed on some of the reaction cards. |
| Root cause | Pending |
| Action | 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. |
| Quantity | 32 kits dist. by recalling firm |
| Distribution | Nationwide Distribution -- including MN, MI, IL, and NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972030 | STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS Oxoid , Ltd., Sep 8, 1997 |