Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its Access Sensitive Estradiol. [Ref.: B84493; All lots]
The manufacturer states that the product Instructions for Use (IFU) specifies an upper limit for reporting results with the onboard dilution (OBD) assay. This upper limit is two times the stated S5 calibrator concentration (approximately 10,400 pg/mL). However, the manufacturer has discovered that it may report results that are up to three times the stated S5 calibrator concentration (approximately 15,600 pg/mL).
According to the manufacturer, the system software is calculating the results correctly, however, any reported results that are between two and three times above the S5 calibrator level (approximately 10,400 pg/mL and 15,600 pg/mL) have not been validated by the manufacturer.
The manufacturer advises to report any results that is two times greater than the stated S5 calibrator as greater than that value. An updated IFU will be released in mid-April 2021 and affected users should follow the advice listed on the customer letter.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 31 March 2021