CLASS II Device recall · Reported 25 Jun 2014 · FDA Enforcement Report
Roche Modular Analytics Evo Serum Work Area (Swa), Operator's Manual recalled
Roche Diagnostics Operations is recalling Roche Modular Analytics Evo Serum Work Area (Swa), Operator's Manual, distributed nationwide in the US. The recall was initiated on 21 May 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1790-2014
- FDA event ID
- 68294
- Recalling firm
- Roche Diagnostics Operations, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 May 2014
- FDA classified
- 13 Jun 2014
- Reported
- 25 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 21 May 2014 | Recall initiated by company | |
| 13 Jun 2014 | Classified by FDA | +23 days |
| 25 Jun 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Roche Modular Analytics Evo Serum Work Area (Swa), Operator's Manual recalled?
Yes. Roche Diagnostics Operations recalled Roche Modular Analytics Evo Serum Work Area (Swa), Operator's Manual on 21 May 2014. The recall is Class II and its status is Terminated. Recall number Z-1790-2014.
Why was it recalled?
Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.
Which lots are affected?
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,
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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