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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare/PAA Healthcare

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  Class 2 Device Recall GE Healthcare/PAA Healthcare see related information
Date Initiated by Firm April 12, 2013
Date Posted July 15, 2013
Recall Status1 Terminated 3 on September 14, 2015
Recall Number Z-1735-2013
Recall Event ID 65088
Product Classification Sera, animal and human - Product Code KIS
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.
Code Information 510 k exempt No Medical Device Listing number  All batches produced within the last 5 years (143 batches)
Recalling Firm/
Manufacturer		 Paa Laboratories Inc
145 Bethridge Road
Etobicoke Canada Ontario
For Additional Information Contact Mr. Jose A. Restituyo
508-683-2337
Manufacturer 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 Un
FDA Determined
Cause 2		 Under Investigation by firm
Action GE Healthcare notified customers via USPS on April 12, 2013 and April 14, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers being contacted by phone as well. Customers were asked to contact their local customer service representative if the product does not meet their needs. Customers were instructed to call (732) 457-8455 or 301-660-0256. For questions regarding this recall call 609-514-6888.
Quantity in Commerce approximately 280,000 liters
Distribution Worldwide Distribution - USA (nationwide), Novia Scotia, and Canada
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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