Alerte De Sécurité sur Creatinine / Creatinine, List No. 7D64-20, Lot Number 14032HW00 .. Registration Number: 10055310842 (ANVISA)

Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.

Serum creatinine is used to measure and monitor renal function. A falsely elevated patient outcome may lead the physician to believe that the patient has kidney failure. Dialysis may be performed without need. This may lead the doctor to believe that the patient is normal or has abnormal kidney function. A falsely low value may lead the doctor to believe that the patient has normal renal function, when this is not true. Incorrect doses of medications can be administered causing intoxication. A Customer Letter has been distributed to all AEROSET and c8000 customers, recommending discontinuing the use of this kit and storing it for later return to Abbott Laboratories. This communication was distributed to all Aeroset and C8000 customers who received lot 14032HW00. - Identify if you are using or have in stock the product CREATININ LN 7D6420 batch 14032HW00, discontinue use of the product, store the mentioned products in your laboratory for later return to Abbott Laboratories of Brazil Ltda - Diagnostics Division, - Fill in the response protocol and ship to 0xx11 - 5536 7181, for further return. Abbott will perform the material collection and will arrange a refund as soon as possible. Additional information contact the Customer Service Center by calling 0800 119099.