Device product
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 latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.
Z-1070-2018
Product summary
- Event
- Event 79245
- Status
- Terminated
- Classification
- Class II
- Quantity
- 686 units
- Official record key
device-enforcement:Z-1070-2018
Official wording
Reason: All patient serum samples yield a weakly positive test result.
Code information: Lot 21675
Distribution pattern: Worldwide Distribution - United States nationwide , Canada, Korea, Mexico, Trinidad
Derived failure modes
-
Unknown
All patient serum samples yield a weakly positive test result.