Recall Z-1327-2020 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
The Binding Site Group, Ltd.
OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
| Date | Jul 29, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | On July 29, 2019, the firm issued a "Field Safety Notice" to all consignees. The firm requested consignees do the following: 1. For kit NK012.0PT.A lot 422251, please load reagents on-board the analyser and leave overnight, or alternatively for a minimum of 18 hours, prior to running the calibration and validating the curve. The Optilite analyser holds the assay reagent (R012.0PT lot 446963) in a temperature controlled reagent carousel; please leave the reagents on-board the analyser until empty (following stability advice in the insert Section 6). 2. Customers are advised that once the cal |
| Quantity | 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, |
| FDA record | Open on fda.gov |