Reported Jun 25, 2014 · Terminated

Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N)…

Roche Diagnostics Operations, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Roche Diagnostics Operations, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025

Is this the product you have?

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 UsageFully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids

Lot codes and dates: 462 of 462 codes
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
Amount recalled: 462

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Nationwide

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Other recalls from Roche Diagnostics Operations, Inc.

63 in total.

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