Various types of Fetal Bovine Serum Bovine sourced recall: Labeling Error
Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture…
Why was Various types of Fetal Bovine Serum Bovine sourced recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
510 k exempt No Medical Device Listing number All batches produced within the last 5 years (143 batches)
- 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…
- Recalling firm
- Paa Laboratories Inc
- Quantity
- approximately 280,000 liters
- Distribution
- Worldwide Distribution - USA (nationwide), Novia Scotia, and Canada
- Recall date
- July 24, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)