Medical device manufacturer, Abbott GmbH & Co. KG, has issued a medical device safety alert concerning its reagent kits. The affected devices are identified as the following:- A) ARCHITECT HAVAb‐IgG Reagent Kit; B) ARCHITECT HAVAb‐IgM Reagent Kit; C) Alinity i HAVAb IgG Reagent Kit List Number: A) 6C29‐22, 6C29‐27; B) 6C30‐22, 6C30‐27; C) 8P26‐32 Lot Number: A) 90356LI00, 90360LI00; B) 90228LI00, 91012LI00, 90227LI00, 91013LI00; C) 90385LI00
The manufacturer has confirmed that a performance shift for captioned lots of the affected reagent has the potential to generate falsely elevated control and patient sample results.
According to the manufacturer, its preliminary investigation has identified a manufacturing error. Additional information will be provided upon completion of the investigation to help quantify the magnitude of the shift in results. Samples tested using ARCHITECT HAVAb‐IgM, ARCHITECT HAVAb‐IgG and Alinity i HAVAb IgG assays may show falsely elevated results with the captioned lots.
The affected users are requested to immediately discontinue use of, and destroy, any remaining inventory of these seven reagent lots according to their laboratory procedure. In the event they are currently using or have inventory of one of the seven lots, immediately contact the manufacture's Customer Support for replacement material. They are also recommended to review the Field Safety Notice with their Medical Director or Laboratory Management and follow their laboratory protocol regarding the need for reviewing previously reported patient results.
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 actions.
Posted on 4 October 2018