Recall Z-1070-2018 ยท DHR System, Test, Rheumatoid Factor
Stanbio Laboratory, LP
RaPET RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) Product Usage: RaPET RF is intended for the qualitative and semiquantitative detection of rhematoid factor in human serum. The
| Date | Feb 13, 2018 |
| Status | Terminated |
| Reason | All patient serum samples yield a weakly positive test result. |
| Root cause | Component design/selection |
| Action | Recall notification letters were sent to affected consignees on 2/14/2018. The letter identified the affected product, problem and actions to be taken. The letter instructed the consignee to stop using affected products, quarantine products, and exchange the kit for an unaffected one. |
| Quantity | 686 units |
| Distribution | Worldwide Distribution - United States nationwide , Canada, Korea, Mexico, Trinidad |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974370 | RAPET RF Stanbio Laboratory, Feb 17, 1998 |