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Notices & Advisories:
Vendor Recall Affecting Hepatitis A Serology Testing

Abbot Diagnostics has issued a product recall notice affecting Hepatitis A Virus Antibody (HAVAb) tests performed at the Public Health and Microbiology laboratory within the Eastern Health Laboratory Program during the dates of July 29 to August 14, 2018.

Abbott Diagnostics has advised that a performance shift for certain lot numbers of the reagent used MAY generate falsely elevated patient sample results.

The purpose of this correspondence is to alert ALL Newfoundland and Labrador physicians and all other health care providers regarding this potential false positive result for HAVAb tests reported during the affected period. The results should be interpreted in the context of other clinical and laboratory findings. If you have a patient with suspect positive or indeterminate HAVAb results, please re-collect and submit for follow-up testing.





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