Paa Laboratories Recalls Fetal Bovine Serum Due to Mislabeling
Paa Laboratories is recalling approximately 280,000 liters of Fetal Bovine Serum because some products labeled as pure may contain added adult Bovine Serum Albumin.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a labeling discrepancy regarding the presence of additives rather than a high-risk pathogen or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Paa Laboratories Inc is voluntarily recalling approximately 280,000 liters of various types of Fetal Bovine Serum (FBS) and boine-sourced animal sera. These products are used as in-vitro diagnostic devices and as growth-promoting nutrients in cell culture systems. The recall affects 143 batches produced within the last five years, which were distributed worldwide, including in the United States, Nova Scotia, and Canada.
The recall is due to a labeling discrepancy. Current product labeling and data sheets state that FBS Pharma Grade and FBS/FBS Native are pure Fetal Bovine Serum. However, these products may contain added adult Bovine Serum Albumin (BSA) of United States origin, water, and/or cell growth-promoting additives. Other FBS products, including FBS Gold and FBS Standard, described as specialty sera, may also contain adult BSA.
Users of these products should stop using the affected lots and contact Paa Laboratories Inc for further instructions. The products are 510(k) exempt and do not have a Medical Device Listing number.
The recalled product
- 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.
- Manufacturer
- Paa Laboratories Inc
- Hazard
Distribution
Distributed nationwide across the United States.
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