Reported Jun 25, 2014 · Terminated

cobas 6000 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 6000 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: 1,147 of 1,147 codes
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
Amount recalled: 1147

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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