Roche Diagnostics Operations, Inc.: 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.; 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.

Agency Publication Date: October 25, 2016

Affected Products

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 clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.

Not applicable

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. Expired samples are disposed of automatically when their storage time has elapsed. The instrument is intended as accessory for diagnostic use.

Not applicable

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. Automatic retrieval for add-on testing is possible at any time. Expired samples are disposed of automatically when their storage time has elapsed. The instrument is intended as accessory for diagnostic use.

Not applicable

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 barcoded secondary tube for processing on an off-line analyzer.

Not applicable

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 host.

Not applicable

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.

Not applicable

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 connection to the host.

Not applicable

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, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, and erythrocytes, In addition, the analyzer determines specific gravity, color, and clarity. The URISYS 2400 is intended for professional use only.

Not applicable

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 SYSTEMS analyzers.

Not applicable

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.

Not applicable

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 quantitative in vitro determinations using a wide variety of tests.

Not applicable

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 body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

Not applicable

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 in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an im

Not applicable

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 diagnostic laboratories.

Not applicable

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.

Not applicable

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.

Not applicable

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 of sample tubes, liquid level detection (optional) and sample quality detection (optional), as well as recapping of sample tubes (optional).

Not applicable

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 75186

Status: Resolved

Manufacturer: Roche Diagnostics Operations, Inc.

Manufactured In: United States

Units Affected: 17 products (9014 in total)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

Not applicable