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.
Recall
- Recall Number
- Z-1735-2013
- Event Number
- 65088
- Firm
- Paa Laboratories Inc 145 Bethridge Road Etobicoke Canada Ontario
- FEI Number
- 3005557536
- Product Code
- KIS
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- April 12, 2013
- Posted
- July 15, 2013
- Terminated
- September 14, 2015
Description
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.
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
GE Healthcare notified customers via USPS on April 12, 2013 and April 14, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers being contacted by phone as well. Customers were asked to contact their local customer service representative if the product does not meet their needs. Customers were instructed to call (732) 457-8455 or 301-660-0256. For questions regarding this recall call 609-514-6888.
Worldwide Distribution - USA (nationwide), Novia Scotia, and Canada
approximately 280,000 liters