medical Class II Updated 2020-06-03

The Binding Site Group, Ltd. recalls Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A,

Recalled Product

Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)

Hazard / Issue

Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis of rheumatoid arthritis over recovers by 7% in comparison to the reference material RF serum. This could result in reporting abnormal (false positive) results, which may lead to unnecessary additional serological testing and a delay in treatment.

Issued by

FDA

Affected States: AL, AR, AZ, FL, GA, KY, MA, MD, MI, MN, MS, NC, NE, NY, OR, PA, TX, VT, WA, WI

Lot/Code Info: Kit Lot Number: 428224

View official government recall

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