Device product
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.
Z-1735-2013
Product summary
- Event
- Event 65088
- Status
- Terminated
- Classification
- Class II
- Quantity
- approximately 280,000 liters
- Official record key
device-enforcement:Z-1735-2013
Official wording
Reason: 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
Code information: 510 k exempt No Medical Device Listing number All batches produced within the last 5 years (143 batches)
Distribution pattern: Worldwide Distribution - USA (nationwide), Novia Scotia, and Canada
Derived failure modes
-
Unknown
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