FDAFDA · Food and drugs·Recall number Z-1327-2020
OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
Published February 26, 2020 · Recall initiated: July 29, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- The Binding Site Group, Ltd.
- Distributor
- CA, PA, FL, AR, SD, MA, WV, AL, GA, IL, MN, MD, AZ, NC, TN, WA, MI, NY, KY, SC, IN, OR, NE, OH, TX, VT, WA, UT, IA,
- Lot
- Lot # 422251
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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