Events

Device Recall Simplexa Group A Strep Direct 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Focus Diagnostics Inc 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
  • 사례 ID
    73283
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1274-2016
  • 사례 시작날짜
    2016-02-10
  • 사례 출판 날짜
    2016-04-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-06-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144533
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system - Product Code PGX
  • 원인
    Focus diagnostics is recalling the direct amplification discs (dad) supplied with the simplexa hsv 1 & 2 direct (mol2150), simplexa flu a/b & rsv direct (mol2650) and simplexa group a strep direct kits (mol2850) because it may result in a false negative result, a false positive result or error code (s) 500 or 505, and it may result in higher invalid rates.
  • 조치
    A customer notification letter dated 2/10/16 was sent to all their customers who received the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850). The letter informs the customers that Focus Diagnostics is recalling MOL2150 and MOL2650 kits because it may result in a false negative result, a false positive result or Error Code(s) 500 or 505. Additionally, some customers are reporting insufficient specimen volume errors which may result in higher invalid rates. In those cases, the error results in a Report Note Statement of Insufficient Specimen Volume. The letter informs the customers of the recommendations to be taken for the identified kits and the risks involved for positive results, negative results, and delayed results. The letter informs the customers of the actions to be taken. Customers are instructed to sign the achnowledgement form and email the form to Technicalinfo@focusdx.com or fax back to Focus Diagnostics Technical Services at (562) 240-6526 within 10 business days. On 2/11/16, Focus Diagnostics sent to their customers an amendment to the customer notification letter to clarify what is considered an "early Ct", Focus would consider Internal Control (IC) Ct's less than 25 as "early Ct". Customers are informed that if an internal control Ct is less than 25, additional testing may be necessary. On 2/15/16, Focus Diagnostics sent to their customers an amendment to the customer notification letter to inform them to determine if they had instances of early Cts less than 25, then to please refer to Section III  Analyzing Runs, pages 6-10 and 6-15 in the Focus Diagnostics, Operator Manual for Integrated Cycler Studio 6.0  For Use with IVD Assays in the USA. Also, for a more detailed analysis, customers are instructed to view excerpts from the ICS Operator Manual covering Section III, pages 6-10 and 6-16. On 3/17/16,

Device

Device Recall Simplexa Group A Strep Direct
  • 모델명 / 제조번호(시리얼번호)
    Item Number MOL1451, Lot/Serial: 151870, 152535,152359, 152550, 152551, 152756, 152770, 160008, 160009, 160198, 160201, 160248, 160262.  Item Number MOL1455, Lot/Serial: 29230, 29232, 29233, 29453, 29454, 29669, 29670, 29671, 29689, 29690, 29691, 29692, 29845, 29846, 29847, 29848, 29849, 29850, 30271, 30272, 30273, 30274, 30275, 30609, 30610, 30611, 30612, 30613, 30615, 30616, 30617, 30619, 30620.   3M Manufacturing Lot# (Pouch and White Box of 24 DAD): 2140887, 2140332, 2127423, 2159531, 2154010, 2165240, 2173319, 2169601, 2176090, 2181518, 2181519, 2198924, 2163486, 2171337, 2176091, 2165236, 2183651, 2185129, 2216981, 2213066, 2210371, 2208204, 2205280, 2255456, 2255456, 2225778, 2230958, 2233449, 2265481 2258543.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of: TX, CA, MA, NY, WA, MI, ME, IN, NJ, WV, OH, PA, HI, NH, CO, MN, FL, SC, IN, IA, TN, OR, AZ, WI, TN, IL. and the countries of: Australia, Brazil, Canada, Dominican Republic, Denmark, Ecuador, France, Germany, Israel, Kuwait, Spain, Sweden, Slovenia, Thailand, and United Kingdom.
  • 제품 설명
    Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) || Model Number: MOL2850, MOL1451, MOL1452, MOL1455
  • Manufacturer
    Focus Diagnostics Inc

Manufacturer

Focus Diagnostics Inc
  • 제조사 주소
    Focus Diagnostics Inc, 11331 Valley View St, Cypress CA 90630-5366
  • Source
    USFDA