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Roche Diagnostics Operations Recalls
127 recalls on record · December 12, 2012 to March 11, 2026 · Medical Devices
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 29, 2013Medical DevicesFDA
Roche Diagnostics Operations, Inc. recalls Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Pro
Hazard: When using the cobas e 602 module, Diluent Multiassay may be used for autodilution of certain assays instead of Diluent Universal. This may cause incorrect results under specific circumstances if all of the following conditions are met simultaneously: More than a total of 2000 reagent kits or diluents have been registered on the cobas e 602 modules within one system core, and two different diluent
April 24, 2013Medical DevicesFDA
Roche Diagnostics Operations, Inc. recalls CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantit
Hazard: Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or quality standards. Errors have been confirmed with the EAN 13 barcodes which should not be used for patient or operator identification.
April 24, 2013Medical DevicesFDA
Roche Diagnostics Operations, Inc. recalls ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to qu
Hazard: Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or quality standards.
April 10, 2013Medical DevicesFDA
Roche Diagnostics Operations, Inc. recalls Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas¿ CT
Hazard: Certain lots of Reagent reservoirs, may not have a separation in the lower part of the reservoir. As a consequence, pipetting errors can occur due to uneven distribution of reagent. These pipetting errors may lead to delayed results and wasted reagent.
January 30, 2013Medical DevicesFDA
Roche Diagnostics Operations, Inc. recalls Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer.
Hazard: A software security issue with Oracles TNS-Listener component has been identified. TNS-Listener is supplied with the Roche COBAS INTEGRA 400/400 plus Analyzers. The Oracle TNS-Listener can be considered as an authentication and redirection component between the client and the database inside the Roche product. This means an attacker could register their own non-Roche database via remote access
December 19, 2012Medical DevicesFDA
Roche Diagnostics Operations, Inc. recalls Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of p
Hazard: It has been determined that cobas b 123 Fluid Pack COOX cuvettes for lot numbers 21426121 and 21426171, exhibit a significant increase in the out-of-box failure rate caused by a change in the thickness in the cuvette layer. Internal investigations found the altered thickness of the cuvette was due to production equipment settings. Cuvettes were produced within specifications, but within the upper
December 12, 2012Medical DevicesFDA
Roche Diagnostics Operations, Inc. recalls Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system f
Hazard: On cobas c 701 and cobas c 702 modules of the Cobas 8000 series analyzer, a mismatch between the reagent probe positioning and the aspirated reagent volumes under certain conditions can lead to insufficient reagent pipetting. This may affect patient sample and controls recovery for the following tests: Alkaline Phosphatase (ALP2), Alanine Aminotransferase (ALT), Bicarbonate (CO2-L), Creatinine (C