Binding Site Group Recalls Rheumatoid Factor Kits Due to Calibration Error
The Binding Site Group is recalling 30 Rheumatoid Factor kits distributed in California because calibration errors may cause falsely abnormal test results.
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, but the hazard is limited to potential diagnostic errors leading to unnecessary testing rather than direct physical injury or death, fitting the Moderate criteria for low-risk issues.
Plain-English summary
The Binding Site Group, Ltd. is recalling 30 Rheumatoid Factor (RF) Kits for use on SPAPLUS, for in-vitro diagnostic use. The affected product code is LK151.S.A. with UDI 05051700018319. The specific lot number is 428217, with an expiry date of 30-APR-2020. These kits were distributed in California.
The recall was initiated because the rheumatoid factor (RF) calibrator values over-recover in comparison to the reference material RF serum. This discrepancy could result in reporting falsely abnormal results, which may lead to unnecessary additional serological testing for patients.
Healthcare facilities and laboratories that have received these kits should stop using them and contact The Binding Site Group, Ltd. for instructions on returning or disposing of the product. Consumers who have had tests performed using these kits should consult their healthcare provider if they have questions about their results.
The recalled product
- Product
- Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
- Manufacturer
- The Binding Site Group, Ltd.
- Hazard
- Affected units
- 30
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)
- Lot 428217 (Expiry date: 30-APR-2020
Distribution
Distributed in 1 state:
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