Events

Recall of GE Healthcare/PAA Healthcare

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Paa Laboratories Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65088
  • Event Risk Class
    Class 2
  • Event Number
    Z-1735-2013
  • Event Initiated Date
    2013-04-12
  • Event Date Posted
    2013-07-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117863
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Sera, animal and human - Product Code KIS
  • Reason
    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.
  • 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.

Device

GE Healthcare/PAA Healthcare
  • Model / Serial
    510 k exempt No Medical Device Listing number  All batches produced within the last 5 years (143 batches)
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide), Novia Scotia, and Canada
  • 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.
  • Manufacturer
    Paa Laboratories Inc

Manufacturer

Paa Laboratories Inc
  • Manufacturer Address
    Paa Laboratories Inc, 145 Bethridge Road, Etobicoke Canada Ontario
  • Manufacturer Parent Company (2017)
    Paa Laboratories Inc
  • Source
    USFDA