Z-1070-2018 Class II Terminated
FDA device recall Z-1070-2018 was initiated by Stanbio Laboratory, LP on February 13, 2018 and is designated Class II. Reason for recall: All patient serum samples yield a weakly positive test result. The recall status is terminated (terminated September 27, 2018). Affected quantity: 686 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- February 13, 2018
- Termination Date
- September 27, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 686 units
Product 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 for Recall
All patient serum samples yield a weakly positive test result.
Distribution Pattern
Worldwide Distribution - United States nationwide , Canada, Korea, Mexico, Trinidad
Code Information
Lot 21675