FDAFDA · Food and drugs·Recall number Z-1269-2014
AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.
Published April 2, 2014 · Recall initiated: February 11, 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
Marketing the devices outside 510(k) requirements
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- AMS Diagnostics, LLC
- Distributor
- Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX.
- Lot
- Model Numbers: 40072, 40146, 80146. Lot codes: 131083, 131084, 131085, 131086, 131087, 131088, 131089, 1310810, 1310811, 1310812, 1310813, 1310814, 1310815, 141081.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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