FDA Medical Device Recalls (openFDA)
Paa Laboratories Inc: 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
- Recalling firm
- Paa Laboratories Inc
- 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.
- Status
- Terminated
- Initiated
- 2013-04-12
- Posted
- 2013-07-15
- Terminated
- 2015-09-14
- 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
- Root cause
- 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
- approximately 280,000 liters
- Distribution
- Worldwide Distribution - USA (nationwide), Novia Scotia, and Canada
- Lot, serial or model codes
- 510 k exempt No Medical Device Listing number All batches produced within the last 5 years (143 batches)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KIS
- Firm FEI
- 3005557536
- Firm city
- Etobicoke Canada
- Firm state
- Ontario
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28