Binding Site Human IgM Kit — Class II medical device recall Z-0477-2019
Terminated recall by The Binding Site Group, Ltd., reported 2018-11-28, distributed in AR, FL, IL, IN, MD, NC, NE, NJ…. After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a redu
| Recall number | Z-0477-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Binding Site Group, Ltd., Birmingham, N/A, United Kingdom |
| Recall initiated | 2018-07-25 |
| Classified | 2018-11-16 |
| Reported by FDA | 2018-11-28 |
| Terminated | 2021-04-27 |
| Distributed | AR, FL, IL, IN, MD, NC, NE, NJ, NY, PA, SD, VA, WA, WV |
| Quantity | 108 |
| Reason classes | potency |
| Lot numbers | 407483-1, 407483-2 |
| Model numbers | NK012.S |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0477-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.