FDA-Device2013-07-24Class II

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.

Paa Laboratories Inc
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

Sold states
Worldwide Distribution - USA (nationwide), Novia Scotia, and Canada
Affected count
approximately 280,000 liters
Manufactured in
145 Bethridge Road, N/A, Etobicoke, Ontario, Canada
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1735-2013

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