FDAFDA · Food and drugs·Recall number Z-1529-2014
Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination of ALT 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 labs.
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¿ ALT Reagent (Product reorder number SA1046 Lot F3604)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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