Binding Site Rheumatoid Factor Kit Recalled for Control Value Deviations
The Binding Site Group is recalling Rheumatoid Factor kits because low and high controls are returning results above assigned values.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the issue involves control value deviations without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
The Binding Site Group, Ltd. is recalling 49 Rheumatoid Factor (RF) Kits for use on SPAPLUS, Product #LK151.S.A. The recall affects Lot #416595, which has an expiration date of 31/03/2018 and UDI #05051700018319. The kits are intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser.
The recall was initiated because the low and high controls for the product are returning results above the assigned values. This issue may affect the accuracy of the test results.
US distribution was made to California, with 32 kits further distributed. There was no foreign, military, or government distribution. Users should contact the recalling firm for further instructions.
The recalled product
- Product
- Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This…
- Manufacturer
- The Binding Site Group, Ltd.
- Hazard
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 (3)
- Lot #416595
- Exp. 31/03/2018
- UDI #05051700018319
Distribution
Distributed in 1 state:
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