FDAFDA · Food and drugs·Recall number 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 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.
Published December 19, 2018 · Recall initiated: November 6, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- The Binding Site Group, Ltd.
- Distributor
- U.S Distribution to states of: CA, IL, PA, FL, NE, WA, IN, NY, SD and VA,
- Lot
- Lot 413849
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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