Roche Molecular Systems, Inc. recalls cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
Read the official notice →- Date
- 2021-10-20
- Country
- United States
- Brand
- Roche Molecular Systems
- Product
- cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution and the countries of…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Roche Molecular Systems recalls
- 2023-02-15
USRoche Molecular Systems, Inc. recalls cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number…
The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress,…
FDA · DeviceRoche Molecular Systems, Inc.Domestic distribution nationwide. Foreign distribution worldwide.Official notice →- 2022-10-26
- US
Roche Molecular Systems, Inc. recalls cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing…
Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.
FDA · DeviceRoche Molecular Systems, Inc.International distribution in the countries of Austria, Belgium, Czech…Official notice → - 2022-04-06
- US
Roche Molecular Systems, Inc. recalls cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases…
FDA · DeviceRoche Molecular Systems, Inc.Worldwide distribution - US Nationwide distribution in the states of CO, IL,…Official notice →
Other drugs & medical recalls in the United States
- 2021-10-20
- US
Inpeco S.A. recalls FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient…
FDA · DeviceInpeco S.A.Domestic distribution nationwide . Foreign distribution worldwide.Official notice → - US
Medtronic Sofamor Danek USA Inc recalls Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Engraving on implants may not match what is listed on the pouch labels.
FDA · DeviceMedtronic Sofamor Danek USA IncDistribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WVOfficial notice → - US
BioMerieux SA recalls MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
Under certain conditions, there is a risk for a false negative result.
FDA · DeviceBioMerieux SAWorldwide distribution - US Nationwide distribution and the countries of…Official notice → - US
Bio-Rad Laboratories, Inc. recalls BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen…
A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs.
FDA · DeviceBio-Rad Laboratories, Inc.Worldwide distribution - U.S Nationwide distribution including in the states…Official notice → - US
Philips North America LLC recalls Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
Customers were not notified of previous recalls associated with various defibrillator models.
FDA · DevicePhilips North America LLCU.S.: CA, CT, FL, GA, IN, MI, MO, NJ, NY, OH, TX, and WA. International…Official notice → - US
W L Gore & Associates, Inc. recalls Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal…
Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.
FDA · DeviceW L Gore & Associates, Inc.International distribution to the countries of Italy & Lebanon.Official notice →