Events

Safety Alert for Technical Name: TECHNO - ANVISA registration number: 80004040145. Risk class: II - Affected model: 009895 - Affected lots: 212; 318; 375; 377; 490; 492; 493; 497; 507; 541; 545; 1017; 1018; 1026; 1049; 1050; 1064; 1065; 1066; 1080; 1084; D0104; D0197 (see Distribution Map IN ANNEX)

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by DIAMED LATINO AMÉRICA S.A.; DIAMED GMBH.

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
  • Event ID
    1770
  • Date
    2015-12-15
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    Customers who do not use Techno for Lu (a) E Lu (b) antigens (Lutheran Antigens) are not subject to the risk of reading incorrect results.
  • Reason
    Adverse reactions weaker than the expected may be observed for antigens lu (a) e lu (b) (antigens lutheran) when tested in the bio-rad techno equipment in internal batteries better than 24 samples, for what a long period of dispensation is necessary.
  • Action
    a) Risk classification according to notification form: III (Situation in which there is a low probability that the use or exposure to a health product may have adverse health consequences // b) Classification of the field action: UPDATE, CORRECTION OR COMPLEMENTATION OF THE INSTRUCTIONS FOR USE // c) Field action code: AC 2015/03 // d) Recommendations to users and patients: WE RECOMMEND THAT CUSTOMERS FOLLOW THE FOLLOWING INTRUTIONS WHEN THE ANTIGENS LUTHERAN WERE TESTED:. TEST NUMBER: PR45A [PRODUCT NAME: ANTIGEN: ANTI-LUNE / Lub (5123)] PRODUCT CODE: 006031 (ID CARD IDENTIFICATION ID NO: 51230) LIMITED BATTERY SAMPLE QUANTITY BY TECHNO: 24 SAMPLES / BATTERY , TESTED ONLY FOR THIS TEST CODE, (ii). TEST NUMBER: PR44H [TEST NAME: ANTIGEN: ANTI-LAMINE (5031)] PRODUCT CODE: 007351 (ID CARD IDENTIFICATION ID NO: 50310) LIMITATION OF BATTERY SAMPLES BY TECHNO: 24 SAMPLES / BATTERY - NOTE : CAN BE TESTED ON THE SAME BATTERY WITH THE PR44I TEST; (iii). LIMITATION OF SAMPLE QUANTITY BY BATTERY ON TECHNO: 24 SAMPLES / BATTERY - NOTE: This product has been tested and found to comply with the limits for a Class B digital device, : CAN BE TESTED ON THE SAME BATTERY WITH THE PR44H TEST; (iv). FOR TESTING: PR42A [TEST NAME: ANTIGENIC PROFILE: P1-Lea-Leb-Lua-Lub-ctl (5037)] PRODUCT CODE: 008510 (ID CARD ID NO: 50371) LIMITATION OF BATTERY SAMPLE QUANTITY NO TECHNO: 24 SAMPLES / BATTERY - NOTE: CAN BE TESTED ON THE SAME BATTERY WITH THE PR41A // TEST (SEE NOTICE TO CUSTOMERS AND NOTIFICATION SCREEN)

Device

Technical Name: TECHNO - ANVISA registration number: 80004040145. Risk class: II - Affected model...

Manufacturer

DIAMED LATINO AMÉRICA S.A.; DIAMED GMBH