FDAFDA · Food and drugs·Recall number Z-0463-2013
Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use.
Published December 12, 2012 · Recall initiated: October 24, 2012
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
Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values 0 IU/ml standard reducing the slope of the standard curve requiring more frequent sample dilutions.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sekisui Diagnostics Llc
- Distributor
- Nationwide Distribution-including the states of FL, IN, NC, OH, UT, and WA.
- Lot
- Lot # 120827, exp 11/27/2012
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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