In a significant development, Grifols, a private plasma collection company, has amended its previous reports concerning serious incidents involving donors, now acknowledging only six cases since 2018, including three fatalities in Winnipeg. This revision comes in the wake of Health Canada’s critical investigations into the company’s operations across Canada, prompting a temporary suspension of plasma collection activities.
Revised Incident Reports
Grifols, which operates 17 plasma donation centres across six provinces, initially reported 25 serious adverse reactions, but following an internal review, the company stated that many of these incidents did not align with the regulatory definition of a serious adverse reaction. Health Canada has since accepted Grifols’s revised figures, which significantly reduce the number of reported incidents.
The company attributed the discrepancies to misclassification, asserting that the correct count of serious incidents now stands at six. These include one case from Prometic Plasma Resources in Winnipeg in 2018, additional incidents in 2021 and 2023 at various locations, and two more fatalities in Winnipeg in 2025 and 2026.
Health Canada’s Oversight
Health Canada defines a “serious adverse reaction” as an unexpected response from a plasma donor leading to severe consequences, such as hospitalisation or death. The agency mandates that any such incidents be reported within a specific timeframe, ensuring that safety protocols are strictly adhered to.
In June, Health Canada disclosed that it had documented 27 serious adverse reactions since 2018—25 linked to Grifols and its predecessor companies, and two associated with Hema-Québéc. The recent findings underscore the importance of accurate reporting and classification in the plasma donation sector.
Investigations and Public Response
Grifols has faced mounting scrutiny following multiple critical incidents, including the deaths of two donors in Winnipeg. Concerns have arisen over operational procedures, with reports of staff inadequately responding to alarms and allowing donors with potential health risks to proceed with donations.
In light of these concerns, Grifols temporarily halted its plasma collection operations on August 14, pending the outcome of Health Canada’s investigations. Despite these challenges, Grifols maintains that it informs donors of the risks associated with plasma donation procedures.
Legal Actions and Future Implications
In a related legal matter, a Manitoba man has filed a lawsuit claiming he sustained an acute kidney injury while donating at Grifols’s Taylor Avenue location in 2023. While Grifols asserts that donors are made aware of potential risks, the case remains unresolved in court.
The incidents previously excluded from the serious adverse reaction count spanned several provinces and occurred between 2018 and 2025. Health Canada’s spokesperson reiterated that no modifications to the reports resulted from the reclassification process, highlighting the responsibility of blood collectors to accurately report and classify any adverse reactions.
Why it Matters
The recalibration of Grifols’s reporting on serious adverse reactions raises critical questions about safety standards within the plasma donation industry, particularly regarding donor well-being and operational transparency. As the company navigates regulatory scrutiny and ongoing investigations, the implications for public trust and the future of plasma collection in Canada are significant. Ensuring the safety of donors must remain a top priority for all operators in this vital health sector.
