FDA Enforcement
Class II
Terminated
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.
Recall: Z-1070-2018
·
Reported March 21, 2018
Enforcement
- Recall Number
- Z-1070-2018
- Event ID
- 79245
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Stanbio Laboratory, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 21, 2018
- Initiation Date
- February 13, 2018
- Classification Date
- March 15, 2018
- Termination Date
- September 27, 2018
- Address
- 1261 N Main St, Boerne, TX, 78006-3014, United States
Description
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.
Reason
All patient serum samples yield a weakly positive test result.
Code Info
Lot 21675
Distribution
Worldwide Distribution - United States nationwide , Canada, Korea, Mexico, Trinidad
Quantity
686 units