Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
OPTILITE IgM Kit Recalled by The Binding Site Group, Ltd. Due to There is a potential that users may experience...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact The Binding Site Group, Ltd. directly.
Affected Products
OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
Quantity: 3294 kits
Why Was This Recalled?
There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in potential false patient results which could cause a delay until repeat testing is performed.
Where Was This Sold?
This product was distributed to 28 states: AL, AZ, AR, CA, FL, GA, IL, IN, IA, KY, MD, MA, MI, MN, NE, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VT, WA, WV
About The Binding Site Group, Ltd.
The Binding Site Group, Ltd. has 28 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report