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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68294

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 21, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Roche Diagnostics Operations, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

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.

Z-1790-2014
Recall number
Z-1790-2014
Initiated
May 21, 2014
Classification
Class II
Status
Terminated
Quantity
462

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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,

Distribution pattern

US Nationwide Distribution

device · product 2 of 3

cobas 6000 analyzer series Operators Manual Roche cobas; 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.

Z-1791-2014
Recall number
Z-1791-2014
Initiated
May 21, 2014
Classification
Class II
Status
Terminated
Quantity
1147

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

1848-01, 1848-03, 1848-04, 185503, 1845-15, 186211, 1857-12, 186225, 1862-16, 1862-10, 185715, 185817, 1865-05, 1862-27, 1858-35, 1859-30, 1859-33, 1863-05, 1867-14, 1844-16, 1868-14, 1844-15, 1870-06, 1870-14, 1857-13, 1870-05, 1868-08, 1867-16, 1868-02, 1865-04, 1867-13, 1862-24, 1872-14, 1872-15, 1871-05, 1873-05, 1871-12, 1871-14, 1873-10, 1872-01, 1871-09, 187015, 1873-01, 1871-04, 187113, 187202, 1871-07, 1873-02, 1866-13, 185731, 1867-20, 1868-01, 01873-03, 1874-06, 1872-12, 1867-19, 1985-08, 1872-07, 1874-05, 1983-10, 1983-09, 1872-03, 1871-01, 1867-06, 1844-14, 1985-10, 187102, 1988-08, 1872-06, 1871-03, 1988-02, 1984-05, 1985-07, 1987-14, 1871-11, 187018, 198703, 1990-04, 1987-04, 1983-08, 199902, 1870-16, 1990-02, 1991-08, 1852-15, 1984-01, 198803, 199110, 198711, 1987-10, 199010, 1988-11, 1991-18, 1990-05, 1988-14, 1991-09, 1991-11, 199112, 1991-13, 1991-14, 1988-10, 1910-02, 1909-09, 1909-10, 1991-15, 1910-03, 1910-05, 190914, 1991-17, 1991-16, 1985-06, 1919-05, 1909-08, 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Distribution pattern

US Nationwide Distribution

device · product 3 of 3

cobas 8000 analyzer series Operators Manual Roche cobas 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.

Z-1792-2014
Recall number
Z-1792-2014
Initiated
May 21, 2014
Classification
Class II
Status
Terminated
Quantity
149

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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Distribution pattern

US Nationwide Distribution