Z-1327-2020 Class II Terminated
FDA device recall Z-1327-2020 was initiated by The Binding Site Group, Ltd. on July 29, 2019 and is designated Class II. 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 po… The recall status is terminated (terminated January 13, 2022). Affected quantity: 3294 kits.
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2020
- Initiation Date
- July 29, 2019
- Termination Date
- January 13, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3294 kits
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.
Distribution Pattern
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,
Code Information
Lot # 422251