Binding Site Optilite Beta-2-Microglobulin Urine Kit recall
Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham…
Why was Binding Site Optilite Beta-2-Microglobulin Urine Kit recalled?
The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
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 407460, UDI 05051700017688
- Product
- Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham…
- Recalling firm
- The Binding Site Group, Ltd.
- Quantity
- 20 kits distributed to the U.S.
- Distribution
- US Distribution was made to CA. There was no foreign/military/government distribution.
- Recall date
- April 11, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)