Z-2110-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2020
- Initiation Date
- October 7, 2019
- Termination Date
- January 11, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 478 kits
Product Description
Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
Reason for Recall
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.
Distribution Pattern
US: AL, AR, AZ, FL, GA, KY, MA, MD, MI, MN, MS, NC, NE, NY, OR, PA, TX, VT, WA, WI OUS: None
Code Information
Kit Lot Number: 428224