FDA Device recall Z-0604-2019
Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators an…
- FDA Device
- Class II
- terminated
- Published 2018-12-19
On 2018-12-19 the FDA classified a Class II recall of Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators an… by The Binding Site Group, citing 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 s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0604-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-06 |
| Published | 2018-12-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | The Binding Site Group |
| Distribution | CA, FL, IL, IN, NE, NY, PA, SD, VA, WA |
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
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.
Identifiers
| code_info | Lot 413849 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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All The Binding Site Group recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0604-2019%22
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