Related Experiment Video
Updated: May 17, 2026
04:54
Iterative Development of an Innovative Smartphone-Based Dietary Assessment Tool: Traqq
Published on: March 19, 2021
Product recall: a Croatian experience (2000-2010)
Tomislav Vuk1, Marijan Barišić, Julijana Ljubičić
1Croatian Institute of Transfusion Medicine, Zagreb, Croatia. tomislav.vuk@hztm.hr
Blood Transfusion = Trasfusione Del Sangue
|November 2, 2012
Summary
Product recalls in transfusion medicine are infrequent and low in scope. Bacterial contamination and lab errors were primary recall drivers, with a decrease in internal errors but an increase in recalls due to biological variability.
Area of Science:
- Hematology
- Transfusion Medicine
- Patient Safety
Background:
- Effective product recall is crucial for preventing adverse events and ensuring patient safety in transfusion services.
- Despite regulatory frameworks, data on the implementation and outcomes of product recall procedures are scarce.
Purpose of the Study:
- To analyze the frequency, reasons, severity, and efficiency of product recall procedures at the Croatian Institute of Transfusion Medicine (CITM) over an 11-year period.
- To identify trends in product recall rates and their underlying causes.
Main Methods:
- Retrospective analysis of product recall data from CITM between 2000 and 2010.
- Categorization of recalls by reason, extent, and severity (Class I, II, III).
Main Results:
- 245 product recalls occurred over 11 years (average 22/year), with low product scope per recall.
- Leading reasons included suspected bacterial contamination (30.2%) and non-conforming lab reports (28.6%).
- Recall rates were 1/3,571 blood products issued and 1/5,447 patients for lab reports.
Conclusions:
- Product recall procedures at CITM were infrequent and of limited scope.
- A decreasing trend in recalls due to internal non-conformities was observed.
- Recalls attributed to biological variability of blood products remained constant or increased.
Related Concept Videos
01:19Pharmacovigilance
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
01:25Drug Regulation
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
01:16Drug Product Stability
The long-term stability of drug products is critical to ensuring their quality, safety, and effectiveness over time. Stability directly influences a product's ability to maintain its intended characteristics, ensuring it performs as expected during its intended shelf life. Key attributes such as drug potency, impurities, dissolution, and other physicochemical measures of performance are tested to assess stability. These parameters indicate how well the product retains its quality over time and...
01:23Investigation of Disease Outbreaks
Multistate foodborne outbreaks pose significant public health risks and require meticulous investigation to identify sources and implement control measures. The Centers for Disease Control and Prevention (CDC) utilizes a dynamic seven-step process for these investigations, integrating data from laboratories, interviews, and environmental assessments to protect public health.Outbreak Detection: The detection of multistate outbreaks typically begins with PulseNet, the CDC's national laboratory...
01:03Drug Control Governance: Regulatory Bodies and Their Impact
Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with a...
01:26Pharmaceutical Poisoning: Potential Scenarios
Pharmaceutical poisoning can occur through various channels, impacting an estimated 2 million hospitalized patients in the U.S. annually with serious adverse drug responses. These scenarios encompass both therapeutic uses, such as drug toxicity, where even standard dosages can lead to severe central nervous system depression, and non-therapeutic exposures, including accidental ingestion by children, and environmental and occupational exposures.Unintentional poisonings often involve exploratory...