Product recall: a Croatian experience (2000-2010).

Abstract

Timely and efficient recall of products known or suspected to be non-conforming is an important measure in the prevention of adverse events and in patients' safety. Product recall in the transfusion service is regulated by professional standards and legal acts, but publications presenting results related to the implementation of these procedures are quite rare. Data from the Croatian Institute of Transfusion Medicine (CITM) on the procedures of product recall during an 11-year period (2000-2010) were retrospectively analyzed. Reasons for product recall, their frequency, level of severity and efficiency of the procedures are presented and discussed. During the study period, there were 245 procedures of product recall, for an average of 22 (18-29) procedures/year, all of low extent (1-25 products). Recall was required for 1/3,571 blood products issued, while the frequency of laboratory test report recalls was 1/5,447 patients. The leading reasons for product recall were suspected bacterial contamination of blood products (30.2%) and suspected or demonstrated non-conformity of laboratory test reports (28.6%). In total, 99 (40.4%) product recalls were categorized as class I, 30 (12.2%) as class II and 116 (47.3%) as class III. According to the available literature data, the product recall procedures were performed quite infrequently by the CITM and were of low extent. There was a remarkable decreasing trend in the rate of product recall due to non-conformities or errors made at the CITM, along with a constant or increasing rate of recalls because of biological variability of blood products.