The Binding Site Group, Ltd. recalls Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018…
- Recall date
- November 6, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1500-2020
- FDA classification
- Class II
- Brand / firm
- The Binding Site Group, Ltd.
- Sold / distributed
- Distributed in CA.
Why it was recalled
It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal results which may lead to unnecessary additional serological testing.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
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