FDAFDA · Food and drugs·Recall number Z-1735-2013
Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.
Published July 24, 2013 · Recall initiated: April 12, 2013
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
Current product labeling band data sheets state that FBS Pharma Grade and FBS/FBS Native are pure Fetal Bovine Serum (FBS). These products may contain added adult Bovine Serum Albumin (BSA)of United States origin, water, and/or cell growth promoting additives. All other FBS products, as listed below, including FBS Gold and FBS Standard, described as specialty sera', may contain adult BSA of Un
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Paa Laboratories Inc
- Distributor
- Worldwide Distribution - USA (nationwide), Novia Scotia, and Canada
- Lot
- 510 k exempt No Medical Device Listing number All batches produced within the last 5 years (143 batches)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.