Events

Safety Alert for 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

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Roche.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-05-05
  • Event Date Posted
    2015-05-05
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150505b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: roche 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 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.

Device

crea plus, crep2, lact2, lactate, glu, trigl/tg, triggb, trig/gb, chol/chol2, hdl-c plus 3rd gene...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: [5 May 2015] Roche 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
  • Manufacturer
    Roche

Manufacturer

Roche