Z-1735-2013 Class II Terminated
FDA device recall Z-1735-2013 was initiated by Paa Laboratories Inc on April 12, 2013 and is designated Class II. 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… The recall status is terminated (terminated September 14, 2015). Affected quantity: approximately 280,000 liters.
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2013
- Initiation Date
- April 12, 2013
- Termination Date
- September 14, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- approximately 280,000 liters
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
Distribution Pattern
Worldwide Distribution - USA (nationwide), Novia Scotia, and Canada
Code Information
510 k exempt No Medical Device Listing number All batches produced within the last 5 years (143 batches)