Binding Site Recalls Optilite Rheumatoid Factor Kits Due to Calibrator Error
The Binding Site Group is recalling 478 Optilite Rheumatoid Factor Kits because a calibrator component over-recovers by 7%, potentially causing false positive results.
- Product
- Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
- Category
- Medical Device
- Distribution
- 20 states