CLASS II Device recall · Reported 3 Jun 2020 · FDA Enforcement Report
Optilite Rheumatoid Factor Kit recalled by The Binding Site Group
The Binding Site Group is recalling Optilite Rheumatoid Factor Kit, distributed in 20 states. The recall was initiated on 7 Oct 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2110-2020
- FDA event ID
- 85366
- Recalling firm
- The Binding Site Group, Birmingham, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Oct 2019
- FDA classified
- 22 May 2020
- Reported
- 3 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 Oct 2019 | Recall initiated by company | |
| 22 May 2020 | Classified by FDA | +228 days |
| 3 Jun 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
Where it was distributed
US: AL, AR, AZ, FL, GA, KY, MA, MD, MI, MN, MS, NC, NE, NY, OR, PA, TX, VT, WA, WI OUS: None
AlabamaArkansasArizonaFloridaGeorgiaKentuckyMassachusettsMarylandMichiganMinnesotaMississippiNorth CarolinaNebraskaNew YorkOregonPennsylvaniaTexasVermontWashingtonWisconsin
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Kit Lot Number: 428224
Where was it sold?
US: AL, AR, AZ, FL, GA, KY, MA, MD, MI, MN, MS, NC, NE, NY, OR, PA, TX, VT, WA, WI OUS: None
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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