Events

ADVIA® Centaur ™ - T3 reagents 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 BAYER DIAGNOSTICS 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 날짜
    2001-01-05
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-reactif-advia-centaur
  • 비고 / 경고
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 recall data from the U.S. and France.
  • 데이터 추가 비고
  • 조치
    The boxes containing the cartridges, the number of which appears in the attached table, are removed for the ADVIA® Centaur ™ - T3 reagents (ref.110741, 110742); - Progesterone (ref.118530); FrT4 (ref.110737, 110738); Ferritin (ref.110745, 110746) from Bayer Diagnostics following a problem in the filling line for some of these cartridges. For example, the ADVIA® Centaur ™ - T3 / lots 9055507 and 9055907 reagent packs containing cartridges ranging from 09061 to 09342 and 13449 to 13534 are being removed from the market. cartridges of another number are not removed. Reagent. T. Progesteron. FRT. Ferritin. Reference. . 110741 (80 tests, 110742 (400 tests, 118530 (50 tests, 110737 (50 tests, 110738 (250 tests, 110745, 50 tests, 110746, 250 tests, reagent lot no. incriminated cartridges 905550. 905590. 886158. 886168. 890128. 894538. 896148. 901908. 908858. 908868. 918228. 901143. 901153. 906833. 910753. 912833. 917343. 889952. 889962. 894822 897962. 898712. 901132. .915361. 917321. 917331. 887001. 887011. 889041. 889971. 896101. 901161. 901671. 906141. 889031. 894841. 908761. No. of the incriminated cartridges 09061 to 0934. 13449 to 1353. 01015 to 0109. 02627 to 0270. 04491 to 0457. 06505 to 0658. .. 51006 to 5109. 55271 to 5535. 56587 to 5667. 57479 to 5756. 61540 to 6162. 64716 to 6480. 70777 to 7086. 76185 to 7638. 78013 to 7812. 83605 to 8369. 86221 to 8630. 51210 to 5129. 53558 to 5364. 60263 to 6034. 64914 to 6499. 67018 to 6709. 69680 to 6983. 70336 to 7044. 71979 to 7206. 74903 to 7500. 75751 to 7583. 55544 to 5 562. 56352 to 5657. 68742 to 6884.. . 52538 to 52643. 54809 to 5497. 60453 to 6053. 71425 to 7151. 73532 to 7361. 75440 to 7552. 80912 to 8099. 82652 to 8273.. . . The complete lot number is a 7-digit code located on the reagent box. . **. The cartridge number corresponds to the last 5 digits located on the barcode of the cartridge read by the system.

Device

ADVIA® Centaur ™ - T3 reagents
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    in-vitro_medical_device
  • Manufacturer
    BAYER DIAGNOSTICS

Manufacturer

BAYER DIAGNOSTICS
  • 제조사 모회사 (2017)
    Bayer AG
  • Source
    LAANSM