Recall Z-1735-2013 ยท KIS Sera, Animal And Human
Paa Laboratories Inc
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.
| Date | Jul 15, 2013 (initiated Apr 12, 2013) |
| Status | Terminated |
| 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 |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | approximately 280,000 liters |
| Distribution | Worldwide Distribution - USA (nationwide), Novia Scotia, and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.