Stanbio Laboratory, LP recalls RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-3…

Recall date

February 13, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1070-2018

FDA classification

Class II

Brand / firm

Stanbio Laboratory, LP

Sold / distributed

Worldwide Distribution - United States nationwide , Canada, Korea, Mexico, Trinidad

Why it was recalled

All patient serum samples yield a weakly positive test result.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.