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 Insight

This FDA Devices action (record #Z-1735-2013) was formally reported on July 24, 2013, with the manufacturer initiating the action on April 12, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Paa Laboratories Inc is listed as the recalling firm, operating out of Etobicoke, Ontario. Federal records indicate approximately 280,000 liters units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: 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, wat… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide), Novia Scotia, and Canada. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.