Devices

Device Recall Modular Analytics

Model / Serial
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.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
US Nationwide Distribution
Product Description
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.
1 Event
- Recall of Device Recall Modular Analytics

Manufacturer

Roche Diagnostics Operations, Inc.

Manufacturer Address
Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
Manufacturer Parent Company (2017)
Roche Holding AG
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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