Freelite Human Lambda Free Kit for use on SPAPLUS recall
Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and…
Why was Freelite Human Lambda Free Kit for use on SPAPLUS recalled?
A change in the calibration curve causing an increase in false prozone flags.
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 #400012, 400257
- Product
- Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and…
- Recalling firm
- The Binding Site Group, Ltd.
- Quantity
- 3,088
- Distribution
- Worldwide Distribution - U.S. (nationwide) and Internationally to the following; Canada, Australia.
- Recall date
- January 25, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)