Recall Z-0477-2019 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 | Nov 17, 2018 (initiated Jul 25, 2018) |
| Status | Terminated |
| Reason | After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a reduction in accuracy within the same day; control results may be out of range one day after running the assay calibration curve. Samples have been shown to be similarly affected. |
| Root cause | Under Investigation by firm |
| Action | On 07/25/2018, the Urgent Field Safety Notice and Field Correction E-back Form were emailed to customers. Customers were advised to cease use of the affected product and to dispose of the kits locally. This notice states that a witness signature of kit disposal is required on the E-back form. This notice needs to be passed on to all those who need to be aware within your organisation or to any organisation where the potentially affected devices have been transferred. Customers with additional questions are encouraged to contact their local firm representative, or customer service via phone at |
| Quantity | 108 |
| Distribution | U.S.: IL, WV, NE, SD, NY, IN, WA, MD, NJ, PA, NC, AR, FL, 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 |