Recall Z-1735-2013— Paa Laboratories Inc
Class II · Terminated
Class II FDA medical device recall by Paa Laboratories Inc, initiated 2013-04-12, terminated 2015-09-14. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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.
- Recalling firm
- Paa Laboratories Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-04-12
- Terminated
- 2015-09-14
- Firm location
- Etobicoke, Ontario, Canada
Product 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.
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.