Events

Rappel de Device Recall Modular Analytics

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Roche Diagnostics Operations, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    68294
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1790-2014
  • Date de mise en oeuvre de l'événement
    2014-05-21
  • Date de publication de l'événement
    2014-06-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-06-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127289
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Cause
    Under certain conditions loose procell/cleancell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.
  • Action
    Roche sent an Urgent Medical Device Correction (UMDC) letter dated May 20, 2014 via UPS Grount (receipt required) to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: 1. Follow the instructions in the Precautions Regarding Handling the Aspiration Tube Filter section in this UMDC; 2. Discontinue performing ProCell/Clean Cell aspiration tube filter check as this maintenance item will be performed by your Roche FSR as a part of service maintenance; 3. If you have distributed the products listed within this UMDC to other sites or facilities, please provide them with a copy of the UMDC; and 4. Complete the faxback form enclosed with this UMDC and fax it to 1-888-410-6620. For questions contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.

Device

Device Recall Modular Analytics
  • Modèle / numéro de série
    1305-31, 1305-21, 1305-22, 1308-35, 1308-36, 130833, 130834, 1308-44, 1310-20, 1418-12, 1307-33, 1421-11, 1417-20, 1423-16, 143115, 1428-07, 1430-16, 1430-17, 1423-15, 1429-15, 1305-40, 1541-05, 1539-15, 1548-15, 1544-11, 1431-14, 1548-17, 1545-03, 1547-20, 1557-12, 1544-06, 1548-08, 1429-13, 1303-31, 1303-32, 1556-16, 1549-04, 1548-16, 1540-20, 1538-10, 1563-06, 1556-17, 1539-13, 1539-14, 1571-12, 1572-19, 1684-05, 1570-14, 1571-13, 1679-13, 1684-06, 1683-17, 1570-17, 1684-07, 1684-08, 1685-16, 1572-20, 1673-01, 1691-17, 1691-19, 1691-18, 1698-05, 1698-06, 1691-14, 1728-10, 1694-19, 1711-17, 1708-20, 1709-03, 1601-01, 1698-03, 1601-03, 1705-20, 1714-18, 1714-19, 1847-02, 1686-01, 1733-17, 1733-19, 1733-16, 1736-06, 1843-02, 1570-15, 1849-01, 1855-15, 1857-22, 1860-10, 1691-20, 1696-05, 1567-01, 1860-24, 1853-02, 1855-10, 1855-11, 1858-02, 1858-03, 1860-12, 1860-13, 1860-14, 1736-04, 1849-02, 1853-01, 1860-11, 1857-23, 1857-24, 1739-19, 1857-25, 1857-26, 1861-18, 1861-19, 1861-23, 1853-03, 1860-16, 1860-23, 1860-15, 1864-16, 1860-19, 1985-13, 1989-19, 1996-02, 1861-20, 1865-19, 1307-34, 1992-19, 1999-16, 1999-17, 1864-19, 1980-15, 1535-09, 1999-20, 1993-01, 1996-01, 1999-18, 1905-05, 1905-03, 1921-03, 1925-03, 1860-22, 1860-20, 1905-01, 1921-01, 1858-04, 1860-17, 1905-02, 1921-02, 1418-03, 1418-04, 1925-04, 1905-06, 1999-19, 2050-04, 2050-03, 2050-06, 2050-07, 2050-05, 1537-15, 2052-01, 2052-02, 2050-08, 1725-18, 1694-20, 1733-18, 2056-22, 2056-23, 1419-12, 1422-17, 1307-41, 1536-04, 2065-12, 1905-07, 1905-08, 1864-17, 1864-18, 2061-20, 2065-06, 1736-03, 2065-13, 2076-18, 2068-24, 2080-02, 2071-24, 2071-23, 2068-23, 2081-05, 2081-06, 2070-01, 2079-19, 2080-01, 2081-04, 2070-02, 2086-14, 2086-20, 2084-16, 2084-17, 2084-18, 2085-09, 2086-17, 2086-18, 2082-39, 2084-05, 2084-12, 2084-13, 2084-14, 2084-15, 2085-05, 2085-07, 2085-08, 2188-05, 2188-06, 2188-07, 2086-15, 2086-16, 2086-19, 2188-08, 2188-09, 2188-10, 2084-06, 2084-07, 2071-22, 2084-08, 2084-09, 2084-10, 2084-11, 2085-04, 2085-10, 2188-04, 2084-19, 2084-20, 2084-21, 2076-19, 2076-20, 2190-10, 2190-19, 2190-20, 2190-06, 2190-07, 2190-08, 2190-09, 2190-11, 2190-12, 2081-07, 2081-08, 2081-09, 2081-10, 2081-11, 2083-04, 2083-05, 2084-22, 2084-23, 2076-21, 2190-13, 2083-06, 2083-07, 2083-08, 2079-18, 2081-12, 2190-14, 2080-03, 2188-36, 2188-37, 2188-38, 2188-31, 2188-34, 2188-35, 2187-33, 2188-39, 2188-40, 2190-17, 2190-18, 2190-21, 2082-40, 2083-01, 2188-32, 2190-03, 2190-04, 2190-05, 2190-15, 2190-16, 1549-02, 2065-04, 2071-20, 2071-21, 2189-40, 2190-01, 2190-02, 2083-03, 2085-18, 2189-37, 2189-38, 2189-39, 2085-16, 2189-36, 2192-24, 1561-12, 1544-10, 2083-02, 2085-17, 1537-17, 2187-36, 2187-37, 2187-38, 2102-06, 2102-07, 2102-08, 2085-12, 2192-21, 2192-22, 2086-12, 2106-28, 2106-29, 2110-09, 2110-10, 2189-01, 2085-13, 2192-28, 2192-29, 2085-14, 2192-26, 2192-27, 2192-31, 2086-23, 2086-24, 2102-03, 2195-23, 2085-11, 2085-15, 2192-25, 2192-32, 1711-16, 2086-25, 2086-26, 2101-39, 2188-03, 2189-04, 2188-01, 2188-02, 2119-13, 2189-05, 2189-06, 2086-13, 2086-21, 2189-02, 2189-03, 2102-04, 2102-05, 2119-14, 2192-18, 2192-19, 2126-07, 2132-14, 2192-20, 2126-08, 2189-07, 2140-02, 1545-05, 1686-03, 2146-17, 2146-18, 2146-19, 2251-16, 2251-17, 2251-18, 2252-02, 2252-04, 2253-15, 2147-05, 2147-06, 2251-19, 2251-20, 2252-03, 2253-16, 2253-17, 2253-18, 2260-11, 2260-12, 2260-13, 2257-08, 2257-09, 2257-10, 2257-11, 2252-05, 2253-19, 2253-20, 2254-01, 2255-20, 2257-04, 2056-21, 2147-04, 2251-15, 2253-12, 2253-13, 2253-14, 2257-05, 2257-06, 2257-07, 1725-19, 1857-27, 2076-22, 2260-17, 2260-18, 2260-19, 2260-20, 2262-11, 2262-12, 1725-20, 1691-15, 2260-14, 2260-15, 2260-16, 2256-01, 1684-02, 2256-02, 2262-16, 2262-17, 2263-12, 2262-19, 2262-20, 2267-20, 2263-13, 2263-14, 1847-01, 2071-25, 2075-20, 2262-18, 2275-11, 2275-12, 2267-17, 2267-18, 2263-16, 2263-17, 2275-14, 2290-05, 2267-19, 2275-09, 2275-10, 2275-13, 1556-12, 2275-15, 2275-16, 2278-07, 2290-06, 2278-08, 2283-16, 2296-20, 1563-04, 2278-09, 2263-15, 2278-10, 2278-11, 2283-17, 1534-12, 1601-02, 2330-19, 2331-01, 1544-13, 2330-20, 2331-02, 2330-16, 2330-17, 2330-18, 1559-13, 1307-35.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). || Product Usage: || Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • Adresse du fabricant
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Société-mère du fabricant (2017)
    Roche Holding AG
  • Source
    USFDA