FDAFDA · Food and drugs·Recall number Z-0688-2013
NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.
Published January 23, 2013 · Recall initiated: November 26, 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
Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Perkinelmer
- Distributor
- Nationwide Distribution.
- Lot
- Lot Numbers: 618201, 619200, 618263
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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