AllClear
PricingSign in
FDADecember 23, 2016device

Optilite IgG4 Kit Product Code: LK009.OPT.A

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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 to do

FDA enforcement status: Terminated

Brands named

binding sitebinding

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

Own something like this?

AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.

Start free — 200 items, no card →