Reported Mar 25, 2020 · Terminated
Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI:…
The Binding Site Group, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The Binding Site Group, Ltd. · 8 Calthorpe Road · Birmingham · N/A
Is this the product you have?
- Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use
- Product codeLK151.S.A
- UDI05051700018319
- Lot codes and dates
- Lot 428217 (Expiry date30-APR-2020
- Amount recalled
- 30 kits
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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