Recalls / —

—#127289

Product

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.

FDA product code

JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Device class

Class 1

Medical specialty

Clinical Chemistry

510(k) numbers

K961481

Affected lot / code info

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.

Why it was recalled

Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.

Root cause (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

Firm

Roche Diagnostics Operations, Inc.

Address

9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern

US Nationwide Distribution

Timeline

Recall initiated

2014-05-21

Posted by FDA

2014-06-14

Terminated

2015-06-04

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #127289. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.