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Stanbio Laboratory, LP recalls RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30
Recalled March 21, 2018 · FDA recall Z-1070-2018 · Stanbio Laboratory
Hazard
All patient serum samples yield a weakly positive test result. · FDA Class II
Units
686 units
Sold at
Worldwide Distribution - United States nationwide , Canada, Korea, Mexico, Trinidad
Description
All patient serum samples yield a weakly positive test result.
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.
Manufacturer(s)
Stanbio Laboratory, LP
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →