Recall Z-2110-2020— The Binding Site Group, Ltd.
Class II · Terminated
Class II FDA medical device recall by The Binding Site Group, Ltd., initiated 2019-10-07, terminated 2022-01-11. It names one FDA 510(k) clearance: K162263. Product: Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components). Reason: 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..
- Recalling firm
- The Binding Site Group, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-10-07
- Terminated
- 2022-01-11
- Firm location
- Birmingham, N/A, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.