Reported Feb 1, 2017 · Terminated
Optilite IgG4 Kit Product Code: LK009.OPT.A
The Binding Site Group, Ltd.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The Binding Site Group, Ltd. · 8 Calthorpe Road · Birmingham, N/A · N/A
Is this the product you have?
- Optilite IgG4 Kit Product CodeLK009.OPT.A
- Lot codes and dates
- Lot #401413
- Amount recalled
- 9 users
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was 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
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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