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Recalls and Alerts

Medical Device Safety Alert: Roche Diagnostics ONLINE TDM Gentamicin assay with Preciset TDM I calibrator


Medical device manufacturer, Roche Diagnostics, has issued a medical device safety alert concerning its ONLINE TDM Gentamicin assay with Preciset TDM I calibrator. The affected products are identified as follows:

  • ONLINE TDM Gentamicin 100 Test c 311, c 501/502 Part number: 04490843190; Serial/Lot number: 119166, 611780, 617623
  • ONLINE TDM Gentamicin 100 Tests c 701/702 Part number: 05841291190; Serial/Lot number: 119167, 611783, 617624
  • ONLINE TDM Gentamicin Mod P calibrator Part number: 03800504190; Serial/Lot number: 119161, 611779

The manufacturer’s investigations have confirmed an increase in native patient sample result recovery of approximately 15-20 % when using ONLINE TDM Gentamicin with recent Preciset TDM I lots 615118, 619681, 126387, 140735. TDM controls and EQA (External Quality Assessment) samples also show an increased recovery of approximately 15%. A combination with TDM control set lot 125783 does not show this effect.

These observations were confirmed for the ONLINE TDM Gentamicin reagent kits for use on cobas c and MODULAR ANALYTICS < P > comparing recovery with previous vs. recent Preciset TDM I lots but also compared to Gentamicin on COBAS INTEGRA (GENTM). The issue is most likely related to the Preciset TDM I calibrator. Based upon internal data the ONLINE TDM Gentamicin reagent is showing an increased recovery. In contrast to these observations, test results obtained by the Roche Gentamicin COBAS INTEGRA assay (GENTM) are not impacted.

According to the manufacturer, false high results of levels of gentamicin may lead to incorrect dosage reduction of drug. Too low dosage may result in the worst case subsequently in sub-therapeutic serum levels of gentamicin. Gentamicin is also used for treatment of contagious infections (e.g. Plague) therefore too low serum levels of drug may also lead to spread of infections. A medical risk for patients cannot entirely be excluded.

The customers are advised to take the following actions:

  • ONLINE TDM Gentamicin (GENT2):
    As a consequence and precautionary measure the customers must stop using ONLINE TDM Gentamicin reagent until further notice.
    Any kits of ONLINE TDM Gentamicin in inventory may be kept until further notice. There is no need to discard the products which are still in shelf life for the time being. The manufacturer will provide a solution within a short time period (4-6 weeks) allowing customers to continue using the Roche ONLINE TDM Gentamicin assay with the Preciset TDM I calibrator.
  • Preciset TDM I:
    The Preciset TDM I calibrator can be continued to be used for all other TDM assays on cobas c and MODULAR ANALYTICS < P >(except for GENT2) and also for all TDM (including GENTM) on COBAS INTEGRA. There is no need to discard the products which are still in shelf life for the time being.

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 May 2016

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Last Revision Date : 24 May 2016