Events

Alerte De Sécurité sur Trade Name: ChoiceLine 10 Technical Name: URINE TEST TAPE ANVISA Registration Number: 10287410230 Hazard Class: II Model Affected: Serial Numbers Affected: ChoiceLine 10 lots in Brazil (distributed + stock): 11517901; 11517902; 20203401; 20203402; 20339301; 20339302; 22451002; 22933201; 22933202; 23203301; 23203302.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    2149
  • Date
    2016-09-30
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    RECOMMENDATION TO USERS / CUSTOMERS: 1) Please note that the following corrected text should be considered in the use instruction: In the "Accuracy" section of the usage instruction table, the correct classification of the bacteria should read as: Nitrite: = 90 % to 10 ^ 7 gram negative organisms compared to the Griess test. The result of product performance is not affected by the incorrect information contained in the use instruction, so the products can continue to be used as specified. 2) Please fill in the form contained at the end of this notification and send to brasil.tecnovigilancia@roche.com e-mail For further questions and support, please do not hesitate to call our CEAC Service Center - 08007720295 or your representative Roche Diagnóstica Brasil Ltda.
  • Cause
    Roche diagnostics gmbh, the manufacturer of the product abroad, has identified an error in the instruction for use of some urine test strips used for the nitrite test (nit). in brazil, this error applies to the product choiceline 10 test. the error was found in the "accuracy" section of the choiceline 10 test usage table. specific bacteria that should be mentioned as gram-negative are erroneously classified as gram-positive. all batches still within the expiration date of the choiceline 10 test are affected by the problem. it should be noted that the chemical characteristics of the strip measuring system are not affected, ie no erroneous measurement risk is related.
  • Action
    Field Action Code SBN_CPS_2016_017 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will update, correct or supplement the instructions for use.

Device

Trade Name: ChoiceLine 10 Technical Name: URINE TEST TAPE ANVISA Registration Number: 10287410230...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH