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Roche Molecular Systems Recalls
42 recalls on record · August 15, 2012 to February 15, 2023 · Medical Devices
Recalls by year
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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.
December 19, 2012Medical DevicesFDA
Roche Molecular Systems, Inc. recalls DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology
Hazard: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
December 19, 2012Medical DevicesFDA
Roche Molecular Systems, Inc. recalls The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It i
Hazard: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
December 19, 2012Medical DevicesFDA
Roche Molecular Systems, Inc. recalls The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software-
Hazard: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
December 19, 2012Medical DevicesFDA
Roche Molecular Systems, Inc. recalls LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification
Hazard: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
December 19, 2012Medical DevicesFDA
Roche Molecular Systems, Inc. recalls LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a targe
Hazard: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
December 19, 2012Medical DevicesFDA
Roche Molecular Systems, Inc. recalls The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic
Hazard: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
December 19, 2012Medical DevicesFDA
Roche Molecular Systems, Inc. recalls The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument fo
Hazard: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
December 19, 2012Medical DevicesFDA
Roche Molecular Systems, Inc. recalls Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep ins
Hazard: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
November 7, 2012Medical DevicesFDA
Roche Molecular Systems, Inc. recalls cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The pr
Hazard: It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packaged into cobas 4800 BRAF V600 Mutation Test CE-IVD kit lot R03607 and released for distribution. Two control batches manufactured during two process validation studies are involved: PV7711: BRAF Mutant (MUT) Control PV0853: BRAF Wild Type (WT) Control
September 26, 2012Medical DevicesFDA
Roche Molecular Systems, Inc. recalls Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The so
Hazard: When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK software v3.2 series (AL v3.2) there is a potential for wrong results to be assigned to an order.
August 22, 2012Medical DevicesFDA
Roche Molecular Systems, Inc. recalls COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample inpu
Hazard: Certain lots of COBAS AmpliPrep (CAP) S-tube Input (Box of 12 bags 12x24 S-tube and 12x24 S-clip) can cause the sample input tubes to stick in the barcode clips. As a consequence, the CAP instrument will lift both the sample input tube together with the barcode clip from the sample rack, resulting in an aborted run. No erroneous results would be produced if the issue occurs, but samples in proce
August 15, 2012Medical DevicesFDA
Roche Molecular Systems, Inc. recalls Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutation Test, for use wi
Hazard: During the real-time stability testing for the cobas KRAS Mutation Test on the commercial lot PO6778, it was identified that the kit was just within specifications for the codon 61 peak height ratio, and that the kit has trended towards the upper specification limit at the 6 month time point but did passed the 6 month stability testing. The kit is labeled for 9 months shelf life stability. The d