Drugs & medicalClass II

Microgenics Corporation recalls Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303,…

The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.

Read the official notice →
Date
2025-11-05
Country
United States
Brand
Microgenics
Product
Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303,…
Classification
Class II
Units
Worldwide - US Nationwide distribution in the states of AL, OK, NH, NY, WI,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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 Microgenics recalls

  1. 2022-07-06
  2. US
    Drugs & medicalClass II

    Microgenics Corporation recalls QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMUS CAL…

    Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result values when used with the QMS Tacrolimus Immunoassay.

    FDA · DeviceMicrogenics CorporationU.S.: AL, AZ, CA, DC, FL, IA, ID, IL, KY, LA, MA, NE, NJ, NM, OH, OK, PA, SC,…Official notice →
All 2 Microgenics recalls →

Other drugs & medical recalls in the United States

  1. 2025-11-12
  2. US
    Drugs & medicalClass II

    Aero Healthcare recalls Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for…

    Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin…

    FDA · DrugAero HealthcareUS Nationwide.Official notice →
  3. US
    Drugs & medicalClass II

    Zydus Pharmaceuticals (USA) Inc recalls clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC…

    cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

    FDA · DrugZydus Pharmaceuticals (USA) IncNationwide in the USOfficial notice →
  4. US
    Drugs & medicalClass II

    Teva Pharmaceuticals USA, Inc recalls Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only,…

    Subpotent drug; Clavulanate Potassium component

    FDA · DrugTeva Pharmaceuticals USA, IncDistributed in three (3) States: MS, OH, CA.Official notice →
  5. 2025-11-05
  6. US
    Drugs & medicalClass II

    Cepheid recalls Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of…

    As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.

    FDA · DeviceCepheidU.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA,…Official notice →
  7. US
    Drugs & medicalClass II

    Trividia Health, Inc. recalls Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.

    Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management.

    FDA · DeviceTrividia Health, Inc.US Nationwide distribution in the states of NY, VA, FL, OH, CA, KY, NC.Official notice →
  8. US
    Drugs & medicalClass II

    Beckman Coulter, Inc. recalls CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and…

    Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters,…

    FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the states of AL, AR, FL, IL, IN,…Official notice →
See all drugs & medical recalls →