Optilite IgG4 Kit recall
Optilite IgG4 Kit Product Code: LK009.OPT.A
Why was Optilite IgG4 Kit recalled?
A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert
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 #401413
- Product
- Optilite IgG4 Kit Product Code: LK009.OPT.A
- Recalling firm
- The Binding Site Group, Ltd.
- Quantity
- 9 users
- Distribution
- U.S. distribution to the following; FL, TX, PA, CA, MA, WA, MI, CT. No foreign distribution.
- Recall date
- February 1, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)