Medical device manufacturer, Roche, has issued a medical device safety alert concerning all lot numbers of CREA plus, CREP2, LACT2, Lactate, GLU, TRIGL/TG, TRIGGB, TRIG/GB, CHOL/CHOL2, HDL-C plus 3rd generation/HDLC3, LDL_C plus 2nd generation/LDL_C, UA2/UA plus.

The manufacturer has received complaints about falsely low CREA plus results for patients with a toxic level of Acetaminophen under treatment with N-acetylcysteine (NAC).

The manufacturer has received complaints about falsely low CREA plus results for patients with a toxic level of Acetaminophen under treatment with N-acetylcysteine (NAC).

The manufacturer's investigations suggest that the peroxidase reaction is interfered with by certain drugs, causing falsely low recovery.

The manufacturer advises user to be aware that:

• The recovery of Trinder tests may be falsely low when the blood sample is taken while levels of NAC, NAPQI, and Metamizole are still present.
• Venipuncture should be performed prior to the administration of Metamizole. Venipuncture immediately after or during the administration of Metamizole may lead to falsely low results.

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 5 May 2015