Recall record at a glance
| Official record | Z-1735-2013 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Paa Laboratories Inc. |
| Report date | Jul 24, 2013 |
| Recall initiation date | Apr 12, 2013 |
| Quantity | approximately 280,000 liters |
| Location | Etobicoke, Ontario, Canada |
Official 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.
Why the product 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
Distribution information
Worldwide Distribution - USA (nationwide), Novia Scotia, and Canada
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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