Important Safety Alerts

Medical device manufacturer, Abbott Laboratories Limited, has issued a medical device safety alert concerning its multiple ARCHITECT Assays, the affected products are identified as following:

• A) ARCHITECT Complement C3; B) ARCHITECT Immunoglobulin A; C) ARCHITECT Immunoglobulin G; D) ARCHITECT Immunoglobulin M; E) ARCHITECT Apolipoprotein A1; F) ARCHITECT Complement C4; G) ARCHITECT Haptoglobin; H) ARCHITECT Apolipoprotein B; I) ARCHITECT Transferrin
• List Number: A) 9D96; B) 9D98; C) 9D99; D) 1E01; E) 9D92; F) 9D97; G) 9D91; H) 9D93; I) 1E04
• Lot Number: All

The manufacturer informed of a Field Safety Notice (FSN) concerning update to the REAGENTS and SPECIMEN COLLECTION AND HANDLING/ PREPARATION FOR ANALYSIS sections of the Instructions for Use (IFU) for the affected products.

Based on recent fibrinogen interference testing, the EDTA specimen type is no longer acceptable for use with the assays listed in the FSN Section 1 of Appendix A.

For Complement C4 only, greater than 10% negative interference was observed on samples containing elevated fibrinogen concentrations >1512 mg/dL in lithium heparin tubes and >859 mg/dL in sodium heparin tubes. Heparin samples below these fibrinogen concentrations did not show interference. Results should be evaluated by comparing to other clinically relevant information. For all other assays listed in the FSN Appendix A, no interference was observed on heparin tubes at fibrinogen levels up to 1776 mg/dL.

Additionally, based on recent testing, the specimen storage information is being revised for the assays shown in the FSN Section 2 of Appendix A.

Lastly, the active ingredient concentrations are being updated for assays shown in the FSN Section 3 of Appendix A. These concentration changes are informational only; there is no change to reagent formulations.

According to the manufacturer, there is a potential for falsely depressed results due to fibrinogen interference with EDTA specimens for the products listed in the FSN Section 1 of Appendix A. For Complement C4, there is a potential for falsely depressed results due to fibrinogen interference with heparin tubes at the concentrations in the Explanation section.

Until the IFU is updated, all reagent kits will include a kit stuffer with this information.

Affected customers are required to take the following actions:

• Immediately discontinue the use of EDTA plasma samples when using any of the products listed in the FSN Section 1 in Appendix A.
• Review the FSN with Medical Director and follow their laboratory procedures.

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 24 May 2019