FDAFDA · Food and drugs·Recall number Z-1530-2014
Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office laboratories.
Published May 7, 2014 · Recall initiated: March 5, 2014
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
Extremely low absorbance readings.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Alfa Wassermann, Inc.
- Distributor
- US Nationwide Distribution
- Lot
- ACE¿ AST Reagent Product reorder numbers SA1047 (Lot F3609) and RX1047 (Lot F3610)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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