well, this post may not be very helpful for people outside Switzerland or Germany, so the english version of this letter here for our friends outside german-speaking countries:
URGENT Field Safety Notice
GEHC Ref # 90200
To: Head of Sourcing
Head of Quality
RE: PAA Laboratories Fetal Bovine Serum (FBS) 3‐21 100ml and 500ml, Quantum 3‐21 100ml
and 500ml for in vitro diagnostic applications; Mislabeled.
GE Healthcare has become aware of potential product label non‐conformances with the
affected PAA Laboratories Fetal Bovine Serum (FBS) products listed below. Please ensure
that all potential users in your facility are made aware of this notification and that the
instructions below are followed.
Safety
Issues
(1) The FBS products, as listed below, described as ‘specialty sera,’ may contain adult
Bovine Serum Albumin (BSA) of United States origin, water, and/or cell growth
promoting additives.
(2) For FBS product shipped into countries other than the United States, current
product labeling for the products listed below states that the origin of the product is
either Australia or EU approved serum sources. In addition to, or instead of product
of this origin, the product may contain adult BSA of United States origin and/or may
contain Fetal Bovine Serum (FBS) from sources including the United States, Canada,
Argentina, Brazil, and/or Mexico.
Safety
Instructions
Stop using the product and take the actions described in the product correction
section below.
Affected
Product
Details
Product Code Product Name Treatment
A15‐110 500 ml Fetal Bovine Serum
3‐21
Amnion cell tested
A21‐110 100 ml Fetal Bovine Serum
3‐21
Amnion cell tested
U11‐020 100 ml Quantum 3‐21 CE‐certified, Medium for Amnion
and Chorionic Villi Cells
U15‐020 500 ml Quantum 3‐21 CE‐certified, Medium for Amnion
and Chorionic Villi Cells
U11‐022 100 ml Quantum BPL The cultivation and growth of
human lymphocytes
for in vitro diagnostic purposes
U15‐022 500 ml Quantum BPL The cultivation and growth of
human lymphocytes
for in vitro diagnostic purposes
Page 2 of 2
Product
Correction
Return any unused product and request reimbursement. Contact your local customer
service representative for instructions on how to return the product to us.
Contact
Information
[Insert Local Customer Service Contact]
[Insert Local Commercial Contact]
Please be assured that maintaining a high level of safety and quality is our highest priority. If
you have any questions, please contact us immediately per the contact information above.
GE Healthcare confirms that this notice has been notified to the appropriate Regulatory
Agency.
Sincerely,
Nigel Darby Sue Rogers
Vice President, BioProcessing Executive, Quality Assurance
GE Healthcare Life Sciences & Regulatory Affairs
GE Healthcare Life
Sciences
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