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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Product Detail

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.
Recall Number Z-1735-2013
Classification Class II
Code Info 510 k exempt No Medical Device Listing number All batches produced within the last 5 years (143 batches)
Product Distributed Qty approximately 280,000 liters
Reason For Recall 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.

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.