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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Event Detail

Event ID 65088
Product Type Devices
Status Ongoing
Recalling Firm Paa Laboratories Inc
City Etobicoke
State ON
Country CA
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-12
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - USA (nationwide), and countries of: Canada and Novia Scotia.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 510 k exempt No Medical Device Listing number All batches produced within the last 5 years (143 batches) Class II 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 United States origin, water, and/or cell growth promoting additives. approximately 280,000 liters Z-1735-2013
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