Recall Z-0553-2018— The Binding Site Group, Ltd.
Class II · Terminated
Class II FDA medical device recall by The Binding Site Group, Ltd., initiated 2018-01-04, terminated 2020-06-09. It names one FDA 510(k) clearance: K160070. 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 test should be used in conjunction with other laboratory and clinical findings. Reason: The low and high controls for the product are returning results above the assigned values..
- Recalling firm
- The Binding Site Group, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-01-04
- Terminated
- 2020-06-09
- Firm location
- Birmingham, N/A, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 test should be used in conjunction with other laboratory and clinical findings
Reason for recall
The low and high controls for the product are returning results above the assigned values.
Data sourced from openFDA. This site is unofficial and independent of the FDA.