FDAFDA · Food and drugs·Recall number Z-2431-2012
Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. Catalog Number: 101201 For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use.
Published September 26, 2012 · Recall initiated: August 28, 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 with "0" standard. This will reduce the slope of the standard curve requiring the user to make more frequent sample dilutions.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sekisui Diagnostics Llc
- Distributor
- Nationwide distribution: USA including states of: FL, IN, IL, and WA.
- Lot
- Lot Numbers: 120425 and 120601
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.