Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
This recall has been terminated (originally issued October 7, 2019).
- Company
- The Binding Site Group, Ltd.
- Recall Initiated
- October 7, 2019
- Terminated
- January 11, 2022
- Recall Number
- Z-2110-2020
- Quantity
- 478 kits
- Firm Location
- Birmingham United Kingdom
- Official Source
- View on FDA website ↗
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
US: AL, AR, AZ, FL, GA, KY, MA, MD, MI, MN, MS, NC, NE, NY, OR, PA, TX, VT, WA, WI OUS: None
Lot / Code Info
Kit Lot Number: 428224
Root Cause
Process control
Action Taken
The field safety notice was issued from the firm's UK office to their US office. The US office notified affected end users in the US via Field Safety Notice, dated 09 October 2019 that was sent via email on 9 Oct 2019. The FSN stated the following: 1) That it has been identified that the assigned Rheumatoid Factor (RF) calibrator value, for LK151.0PT.A lot 428224, over recovers by 7% in comparison to the reference material RF serum, NIBSC. Ref 64/002 (WHO Standard 64/2). 2) The firm has assessed risk of this over recovery and determined that there is no clinical risk, and that the kit can continue to be used providing the control results are within their specified acceptance ranges. There is however, a risk of reporting abnormal results which may lead to unnecessary additional serological testing. 3) Although the affected kit, lot 428224, may continue to be used, The Binding Site has calculated an adjustment factor of 0.93 that may be applied to sample results in order to align results to the reference material. They advise that to apply the adjustment factor, the final result for the sample should be multiplied by 0.93. Calibrator and control values for future lots of LK151.0PT.A, will be aligned with the reference material. 4) An e-back form (TSWS18) was provided to affected customers along with the FSN. The FSN requests the customer to complete, sign and return the e-back form to Technical.Support@bindingsite.com or to their local Binding Site representative within one week of receiving the notification to confirm that they have received and understood the FSN. 5) If further information is required, contact local Binding Site Representative or Technical Support Group, UK: +44(0) 1214569696, Technical.support@bindingsite.com