Medical device manufacturer, Abbott, has issued a medical device safety alert concerning its ARCHITECT SHBG Reagents. [List numbers (lot numbers): 8K26-20 (01916E000, 00316F000, 01816G000, 00916I000, 07316I000, 00916L000] and 8K26‐25 (01816E000, 00216F000, 01716G000, 00816I000, 07216I000) ].
The manufacturer has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube type may demonstrate a negative shift relative to results generated with serum. SHBG dimer destabilization in EDTA could result in low SHBG measurements by immunoassay.
There is a potential for falsely decreased ARCHITECT SHBG results to be generated when using the ARCHITECT SHBG assay with the Potassium EDTA specimen tube type.
Internal studies have determined use of the Potassium EDTA specimen tube type may result in a decrease in SHBG concentration values of greater than 20% when compared with serum collected in serum tubes. The shift was observed across the full analytical range of the assay.
As a result, an increase in Free Androgen Index / Free Testosterone Index calculations of up to 30% may also be observed when using Potassium EDTA specimen tubes.
Affected users are instructed to discontinue use of the Potassium EDTA specimen tube type with the ARCHITECT SHBG assay according to their laboratory procedures. The issue should be reviewed with their Medical Director to determine if a review of results previously generated using the Potassium EDTA specimen tube type is necessary.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 April 2017