Recall Z-0604-2019 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
The Binding Site Group, Ltd.
Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid format.
| Date | Dec 13, 2018 (initiated Nov 6, 2018) |
| Status | Terminated |
| Reason | Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges. |
| Root cause | Under Investigation by firm |
| Action | On 11/06/2018, the firm, The Binding Site, emailed an "Urgent Medical Device Correction notice" and Field Correction E-back Form to customers. The notice described the product, problem and actions to be taken. Customers were instructed to do the following: 1) Reagents are to be loaded on-board the analyser and left for a minimum of 18 hours prior to running the calibration and validating the curve. Please leave the reagents on-board the analyser until empty. 2) Once calibration is established and validated, reagents must remain on the instrument until the reagent has been fully consumed. 3) |
| Quantity | 60 |
| Distribution | U.S Distribution to states of: CA, IL, PA, FL, NE, WA, IN, NY, SD and VA, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082129 | HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER The Binding Site, Ltd., Feb 10, 2009 |