Reported Jul 24, 2013 · Terminated
Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting…
Paa Laboratories Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Paa Laboratories Inc · 145 Bethridge Road · Etobicoke, Ontario · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- 510 k exempt No Medical Device Listing number All batches produced within the last 5 years (143 batches)
- Amount recalled
- approximately 280,000 liters
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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