Binding Site Recalls Optilite Rheumatoid Factor Kits Due to Calibrator Error
The Binding Site Group is recalling 478 Optilite Rheumatoid Factor Kits because a calibrator component over-recovers by 7%, potentially causing false positive results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (delayed treatment and unnecessary testing) due to false positive results, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
The Binding Site Group, Ltd. is recalling 478 units of the Optilite Rheumatoid Factor Kit (Ref: LK151.OPT.A, Lot 428224). The recall was initiated because the assigned value for the Rheumatoid Factor (RF) calibrator component included in the kit over-recovers by 7% when compared to the reference material RF serum.
This discrepancy could result in the reporting of abnormal (false positive) results. Such errors may lead to unnecessary additional serological testing and a delay in appropriate treatment for patients being evaluated for rheumatoid arthritis.
The affected kits were distributed in the United States to the following states: AL, AR, AZ, FL, GA, KY, MA, MD, MI, MN, MS, NC, NE, NY, OR, PA, TX, VT, WA, and WI. No international distribution is reported. Healthcare providers and laboratories should stop using the affected kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
- Manufacturer
- The Binding Site Group, Ltd.
- Affected units
- 478
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Kit Lot Number: 428224
Distribution
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