Medical device manufacturer, Beckman Coulter, has issued a medical device safety alert concerning its Access AMH Calibrators [Reference: B13128; Lot Number: 989354, 989355; Expiry Date: 2022-02-27; 2022-05-09].
The manufacturer has determined through an internal investigation that the Access AMH Calibrator lots listed above do not meet the open vial stability claim when used on days 61-90 after reconstitution. The open vial calibrator stability from 0 to 60 days is not impacted.
According to the manufacturer, the Access AMH calibrator instability could result in elevated quality control results of up to 20% across the reportable assay range. The Access AMH calibrator instability could result in quality control failures, which could delay the reporting of results.
The manufacturer is instructing affected users to take the following actions: -
The manufacturer will no longer distribute the Access AMH Calibrator lots listed above. Alternate calibrator lots will be available in inventory.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary action.
Posted on 1 March 2021