Optilite Freelite Mx Kappa Free Kit recall
Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
Why was Optilite Freelite Mx Kappa Free Kit recalled?
Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to 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?
Model Number: LK016.M.OPT.A UDI: 05051700019866 Lot Number: 454763
- Product
- Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
- Recalling firm
- The Binding Site Group, Ltd.
- Quantity
- 213 kits in the U.S.
- Distribution
- U.S.: CO, FL, IA, MA, NC, NJ, NY, OH, SD, and UT. O.U.S.: Not provided
- Recall date
- February 10, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)