Recall Z-0818-2010 ยท JWX Kit, Screening, Staphylococcus Aureus
Remel, Inc
Staphytect Plus, packaged in 100- and 500-test boxes, Catalog #DR0850M (100 tests) and #DR0850B (500 tests). Oxoid Ltd., Wade Road, Basingstoke, Hants UK. Latex slide agglutination test for the differentiation of staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccarides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess
| Date | Feb 23, 2010 (initiated Jul 20, 2009) |
| Status | Terminated |
| Reason | The products may give false positive results with some non-Staphylococcus aureus strains |
| Root cause | Process control |
| Action | Thermo Fischer Scientific, Remel Inc. issued letters dated July 20, 2009 via regular mail explaining the reason for recall, risks involved, and requested they discard all remaining product. A Product Inventory Checklist was enclosed to report the amount of product their customer discarded. A second letter dated October 19, 2009 was issued via certified mail. For further information, contact Thermo Fischer Scientific, Remel Inc. at 1-800-255-6730, Extension 3304185. |
| Quantity | 50 boxes (47 DR0850M; 3 DR0850B) |
| Distribution | Nationwide Distribution -- MN, CT, FL, GA, CA, NY, MI, MO, PA, and IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.