Recall Z-1400-2009 ยท GTQ Antistreptolysin - Titer/Streptolysin O Reagent
Remel, Inc
Remel Staphaurex Plus Kit, Catalog No. R30950102 (150 tests) and Catalog No. R30950201 (450 tests), rapid latex agglutination test for the identification of Staphylococcus aureus The responsible firm listed as Remel Europe Ltd, Dartford, England.
| Date | May 19, 2009 (initiated Nov 18, 2008) |
| Status | Terminated |
| Reason | These lots may exhibit false positive reactions with strains of Staphylococcus epidermidis that may result in the mis-identification of Staphylococcus aureus. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were notified of the recall via letter dated 11/20/08 explaining the reason for recall and requesting any remaining units from the lots be discarded. A Product Inventory Checklist was enclosed to report the amount of product remaining in their inventory. Any non-responding consignees were contacted via telephone during the period of 12/30/08 to 1/11/09 to ensure the effectiveness of the recall. When the recall was expanded to include additional lots, the recalling firm issued an Important Medical Device Customer Recall Notice letters dated 3/16/09 again explaining the reason f |
| Quantity | 446 kits |
| Distribution | Worldwide Distribution -- USA and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.