FDA (Devices) recall action 75186

Roche Diagnostics Operations, Inc. recalled 17 products on 2016-11-02

The FDA (Devices) publishes a recall like this one as 17 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 17 pages.

Products: 17
Announced: 2016-11-02
Critical: 0
Units: 153,238

Why these products were recalled

Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–17 of 17

SevereFDA (Devices)··2016-11-02
Roche Recalls cobas 8000 Analyzers Due to Sharp Edge Injury Reports
Roche is recalling cobas 8000 Modular Analyzers and e602 Immunoassay Analyzers after four reports of injury caused by a sharp edge on the sample rack tray.
Product
cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) for clinical use Modular e602: Immunoassay Analyzer Product Usage: The VS II system is a stand-alone, computer-controlled instrument designed to aliquot patient sample from a primary tube to a barcod
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SevereFDA (Devices)··2016-11-02
Roche Recalls cobas e411 Immunoassay Analyzers Due to Sharp Edge Injury Risk
Roche is recalling 9,014 cobas e411 Immunoassay Analyzers because the sharp edge of the sample rack tray center guide rail caused four reported injuries.
Product
cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated sample store. Automatic retrieval for add-on testing is possible at any time
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SevereFDA (Devices)··2016-11-02
Roche Recalls cobas 6000 Series Analyzers Due to Sharp Edge Injury Risk
Roche is recalling cobas 6000 Series analyzers because the sharp edge of the sample rack tray center guide rail caused four reported injuries.
Product
cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clinical Use. Modular e601: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated sample store. A
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SevereFDA (Devices)··2016-11-02
Roche cobas p 612 Pre-Analytical Instrument Recall for Sharp Edge Injury
Roche is recalling cobas p 612 Pre-Analytical Instruments because the sharp edge of the sample rack tray center guide rail caused four reported injuries.
Product
cobas p 612 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative i
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SevereFDA (Devices)··2016-11-02
Roche COBAS INTEGRA 800 Analyzer Recalled Due to Sharp Edge Injury Reports
Roche is recalling COBAS INTEGRA 800 analyzers after four reports of injury caused by the sharp edge of the sample rack tray.
Product
Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use Product Usage: The system cobas p612 is a computer-controlled stand-alone system for aliquoting and sorting of barcoded sample tubes. The system operates with an online conn
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SevereFDA (Devices)··2016-11-02
Roche URISYS 2400 Urine Analyzer Recalled for Sharp Edge Injury Risk
Roche is recalling URISYS 2400 Urine Analyzers because a sharp edge on the sample rack tray caused four reported injuries.
Product
URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is a computer-controlled stand-alone sorting system for sorting barcoded samples. The system has an online connection to the host.
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SevereFDA (Devices)··2016-11-02
Roche Recalls cobas p 471 Centrifuge Units Due to Sharp Edge Injury Risk
Roche is recalling 9,014 cobas p 471 centrifuge units because a sharp edge on the sample rack tray caused four reported injuries.
Product
cobas p 471 centrifuge unit calculator/data processing module, for clinical use Product Usage: The cobas p312 pre-analytical system is a computer controlled stand-alone system for sorting and decapping sample tubes. As an option, the system works with an online connection.
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HighFDA (Devices)··2016-11-02
Roche VS II Aliquoter System recalled due to sharp edge injury risk
Roche is recalling VS II Aliquoter System calculator modules because a sharp edge on the sample rack tray caused four reported injuries.
Product
VS II Aliquoter System calculator/data processing module, for clinical use Product Usage: Elecysy 411 analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.
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SevereFDA (Devices)··2016-11-02
Roche Recalls cobas p 501 Post-Analytical Units Due to Sharp Edges
Roche is recalling 9,014 cobas p 501 Post-Analytical Units because a sharp edge on the sample rack tray caused four reported injuries.
Product
cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The MODULAR PRE-ANALYTICS system is a fully automated system for sample pre-processing, including centrifuging, aliquoting, and barcode labeling, prior to analysis by MODULAR
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SevereFDA (Devices)··2016-11-02
Roche Recalls cobas p 701 Post-Analytical Units Due to Sharp Edges
Roche is recalling 9,014 cobas p 701 Post-Analytical Units because a sharp edge on the sample rack tray caused four reported injuries.
Product
cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The URISYS 2400 Analyzer is a fully automated urinalysis system intended for in vitro qualitative or semi-quantitative determination of urine analytes, including pH, leukocyte
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SevereFDA (Devices)··2016-11-02
Roche Modular Analytics Systems Recalled Due to Sharp Sample Rack Edge
Roche is recalling Modular Analytics Combination Systems because a sharp edge on the sample rack tray caused four reported injuries. The cleaning procedure has been revised to clarify the process.
Product
Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use. Modular E170: Immunoassay Analyzer Product Usage: The Roche COBAS INTEGRA 800/800 CTS Analyzer is fully automated system for clin
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SevereFDA (Devices)··2016-11-02
Roche Recalls cobas 6800/8800 Systems Due to Sharp Edge Injury Risk
Roche is recalling 9,014 cobas 6800/8800 systems because a sharp edge on the sample rack tray caused four reported injuries.
Product
cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: The cobas p512 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged sample tubes. It includes modules for registration and decapping
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SevereFDA (Devices)··2016-11-02
Roche RSD 800A Aliquoting System Recalled Due to Sharp Edge Injury Reports
Roche is recalling 9,014 RSD 800A Aliquoting System calculator/data processing modules because four reports of injury were received from the sharp edge of the sample rack tray.
Product
RSD 800A Aliquoting System calculator/data processing module, for clinical use Product Usage: The Roche/Hitachi MODULAR Analytics System is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quan
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SevereFDA (Devices)··2016-11-02
Roche Recalls cobas 8000 Sorting System Modules Due to Injury Reports
Roche is recalling 9,014 cobas 8000 Sorting System calculator/data processing modules after four reports of injury caused by a sharp edge on the sample rack tray.
Product
RSD 800 Sorting System calculator/data processing module, for clinical use Product Usage: The cobas 8000 Modular Analyze Series is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in bo
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SevereFDA (Devices)··2016-11-02
Roche Recalls cobas p 512 Pre-Analytical Instrument Due to Sharp Edge Injury Reports
Roche is recalling 9,014 cobas p 512 Pre-Analytical Instruments after four reports of injury caused by a sharp edge on the sample rack tray.
Product
cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6800/8800 systems support an automated and integrated workflow to run Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) to be applied in diagnost
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SevereFDA (Devices)··2016-11-02
Roche Modular Pre Analytics EVO/Plus Recall for Sharp Edge Injury Risk
Roche is recalling Modular Pre Analytics EVO/Plus systems because a sharp edge on the sample rack tray caused four reported injuries.
Product
Modular Pre Analytics ( EVO/Plus) Product Usage: The RSD 800A is a computer-controlled stand-online system for decapping, aliquoting and sorting of primary tubes and for producing and sorting bar coded secondary tubes.. The system operates with an online connection to the hos
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SevereFDA (Devices)··2016-11-02
Roche Recalls cobas p 312 Pre-Analytical System Calculator Modules
Roche is recalling 9,014 cobas p 312 Pre-Analytical System calculator/data processing modules due to four reported injuries caused by a sharp edge on the sample rack tray.
Product
cobas p 312 Pre-Analytical System calculator/data processing module, for clinical use Product Usage: The cobas p471 system is an automatic centrifuge module for centrifuging primary sample tubes, which will then be transported to the output module.
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