Reported Jun 25, 2014 · Terminated

cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1,…

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?

cobas 8000 analyzer series Operators
Manual Roche cobas 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: 151 of 151 codes
1125-07
1017-06
1021-03
1021-05
1016-05
1017-01
1124-05
1124-06
1128-02
1132-03
1132-04
1131-08
1132-01
1132-02
1128-05
1128-06
2374-11
1132-05
1132-10
1137-02
1139-08
1139-10
1140-07
1140-10
1140-08
1146-01
1146-02
1146-03
1139-06
1139-07
1139-09
1142-09
1145-10
1138-10
1139-01
1127-08
1138-08
1146-05
1146-06
1147-04
1156-04
1140-01
1147-05
1149-01
1149-07
1149-08
1167-02
1156-06
1158-09
1156-05
1158-10
1139-02
1139-03
1139-04
1139-05
1160-01
1160-05
1171-07
1171-08
1171-09
Amount recalled: 149

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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