OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
Reported: February 26, 2020 Initiated: July 29, 2019 #Z-1327-2020
Product Description
OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
Reason for Recall
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.
Details
- Recalling Firm
- The Binding Site Group, Ltd.
- Units Affected
- 3294 kits
- Distribution
- 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,
- Location
- Birmingham
Frequently Asked Questions
What product was recalled? ▼
OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565. Recalled by The Binding Site Group, Ltd.. Units affected: 3294 kits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 26, 2020. Severity: Moderate. Recall number: Z-1327-2020.
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