Rheumatoid Factor recall
Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor in serum…
Why was Rheumatoid Factor recalled?
The low and high controls for the product are returning results above the assigned values.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #416595, Exp. 31/03/2018; UDI #05051700018319
- 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…
- Recalling firm
- The Binding Site Group, Ltd.
- Quantity
- 49 kits to the U.S. office (32 kits further distributed)
- Distribution
- US Distribution was made to CA. There was no foreign/military/government distribution.
- Recall date
- February 14, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)