Beckman Coulter—Access Thyroglobulin Antibody II Reagents: May Generate Falsely Decreased Results

ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Device Alerts. For more information contact us at clientservices@ecri.org.

In a February 11, 2019, Important Product Notice letter submitted by an ECRI Institute member hospital, Beckman Coulter states that the above reagents may generate falsely decreased results in some patient samples when compared to previously released reagent lots. Beckman Coulter also states that this problem was isolated to a specific lot of human Tg antigen that was used to manufacture the affected lots. Beckman further states that affected lots may generate repeatable (falsely decreased) results by up to 95% in some patient samples. Beckman Coulter states that its investigation indicates the potential for up to 10% to 15% of patient samples to be affected. The manufacturer has not confirmed the...