epa_echo
3 records
fda
19 records
FDA Device Recall: QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and
2024-07-24
Class II — Heater shaker module does not perform heating if the temperature is set below 40¿C for static incubation steps when running IVD protocol QIAamp¿ DSP DNA Mini Kit (cat. no. 61304), Protocol:...
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FDA Device Recall: EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of
2024-04-17
Class II — Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being pro...
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FDA Recall: Qiagen Sciences LLC — Class II
20220112
The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected | Product: QIAstat-Dx Respiratory SARS-CoV-2 Pane...
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FDA Device Recall: QIAcube Connect MDx, Model No. 9003070
2022-09-21
Class II — During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be ...
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FDA Device Recall: FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
2022-09-07
Class II — Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result cou...
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FDA Device Recall: therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
2022-04-27
Class II — False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target...
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FDA Device Recall: QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 69122
2022-01-12
Class II — The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, fals...
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FDA Device Recall: SARS-CoV-2 Antigen Test
2021-02-10
Class II — QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
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FDA Device Recall: therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifyin
2021-02-03
Class II — Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the Q546R higher than previously observed and described within the Instructions Fo...
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FDA Recall: Qiagen Sciences LLC — Class II
20200617
There is a risk for a false mutation positive result in rare cases resulting from a fluorescence artefact. In these rare cases, the controls pass corr | Product: therascreen EGFR RGQ PCR Kit (24), Ref...
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FDA Device Recall: QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Prod
2020-09-16
Class II — There is an increased rate of potential false positive results for the Influenza A (no subtype) target, which may lead to 1) inappropriate antiviral use, 2) erroneous or delayed differentia...
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FDA Device Recall: therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
2020-06-17
Class II — There is a risk for a false mutation positive result in rare cases resulting from a fluorescence artefact. In these rare cases, the controls pass correctly, while a fluorescence artefact in...
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FDA Device Recall: QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed fo
2020-03-18
Class II — When using the Rotor-Gene Q with Software version 2.3.4 completing a LIMs export, the .csv file reports the calculated concentration result value as a logarithmic value, and could lead to ...
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FDA Recall: Qiagen Sciences LLC — Class II
20190828
QIAsymphony software version 5.0.3 - Software issue incorreclty assigns the 2D bar code eluate ID to the sample within the results file. If 2D bar co | Product: QIAsymphony SP SOW 5.0.3, software use...
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FDA Device Recall: QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The
2019-08-28
Class II — QIAsymphony software version 5.0.3 - Software issue incorreclty assigns the 2D bar code eluate ID to the sample within the results file. If 2D bar code eluate IDs are not checked against t...
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FDA Device Recall: Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used wit
2019-08-07
Class I — Kit lots contain a small percentage of damaged Filter-Tips that are leaking when being used with the QIAsymphony SP/AS Instruments (REF 9001297 and 9001301)
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FDA Device Recall: RNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit is
2019-07-03
Class II — The deparaffinization solution contains a contaminant, which leads to reduced lysis efficiency of the affected lot, resulting in significantly reduced yields and less sensitive downstream a...
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FDA Device Recall: EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage:
2018-11-14
Class II — An issue with the power branching printed circuit board (PCB) on the instrument that has the potential to trigger a heater malfunction was discovered. If this failure were to occur, nucleic...
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FDA Device Recall: AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2)
2018-08-15
Class I — Potential for control line not appearing on the test strip
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