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Recall Observatory FDA recall evidence

Device product

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

Z-2110-2020

October 07, 2019

Class II

Product summary

Firm
The Binding Site Group, Ltd.
Event
Event 85366
Status
Terminated
Classification
Class II
Quantity
478 kits
Official record key
device-enforcement:Z-2110-2020

Official wording

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.

Code information: Kit Lot Number: 428224

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.