Drugs & medicalClass II

Randox Laboratories Ltd. recalls RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000

RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature…

Read the official notice →
Date
2023-11-08
Country
United States
Brand
Randox Laboratories
Product
RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
Classification
Class II
Units
US Nationwide distribution including Puerto Rico
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Randox Laboratories recalls

  1. 2024-01-24
  2. US
    Drugs & medicalClass II

    Randox Laboratories Ltd. recalls Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)

    There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human…

    FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution.Official notice →
  3. 2024-01-10
  4. US
    Drugs & medicalClass III

    Randox Laboratories Ltd. recalls SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus…

    A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL.

    FDA · DeviceRandox Laboratories Ltd.NY, WVOfficial notice →
  5. 2023-12-13
  6. US
    Drugs & medicalClass II

    Randox Laboratories Ltd. recalls RANDOX Total Bilirubin.

    Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.

    FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of AR, GA, NC, TN, & PR.Official notice →
  7. 2023-09-27
  8. US
    Drugs & medicalClass II

    Randox Laboratories Ltd. recalls Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215

    there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet…

    FDA · DeviceRandox Laboratories Ltd.US States: GA, OH, OR, PA, TX, VAOfficial notice →
  9. 2023-08-30
  10. US
    Drugs & medicalClass II

    Randox Laboratories Ltd. recalls Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement…

    As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The…

    FDA · DeviceRandox Laboratories Ltd.CA, FL, IL, ME, MI, NC, OH, PA,NJ,Official notice →
  11. US
    Drugs & medicalClass II

    Randox Laboratories Ltd. recalls Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride,…

    (1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be negative and (2) high and outside range for cortisol. (3) There has been a transcription error for Creatinine in…

    FDA · DeviceRandox Laboratories Ltd.Worldwide distribution - US Nationwide distribution in the states of AR, FL,…Official notice →
All 27 Randox Laboratories recalls →

Other drugs & medical recalls in the United States

  1. 2023-11-08
  2. US
    Drugs & medicalClass II

    RAYSEARCH LABORATORIES AB recalls RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical…

    An issue was found in RayCare 5B, 6A, including service packs, where values will not be visible for documents in a read-only state when opened outside the Documents workspace when using document fields configured with…

    FDA · DeviceRAYSEARCH LABORATORIES ABMD, TNOfficial notice →
  3. US
    Drugs & medicalClass II

    Smiths Medical ASD Inc. recalls Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.

    The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).

    FDA · DeviceSmiths Medical ASD Inc.Distribution was made to AZ, CA, FL, HI, IL, IN, MA, MN, MO, MS, NC, NJ, OH,…Official notice →
  4. US
    Drugs & medicalClass II

    Coapt LLC recalls Coapt Dome Electrode, Gen2 system, cutaneous electrode

    Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.

    FDA · DeviceCoapt LLCWorldwide distribution - US Nationwide and the country of Sweden.Official notice →
  5. US
    Drugs & medicalClass II

    Quest Medical, Inc. recalls Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV…

    For administration of intravenous fluids to a patient s vascular system utilizing needle-free components and I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a…

    FDA · DeviceQuest Medical, Inc.US:TX, UT, FL, CA, VA, CO, AL, NV, IL, OK, OH, PA, MO, MN, MT, WA, MI, TN, NY…Official notice →
  6. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and…

    Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure

    FDA · DeviceSiemens Medical Solutions USA, IncNationwideOfficial notice →
  7. US
    Drugs & medicalClass II

    MICROVENTION INC. recalls AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324

    Peripheral coil system detachable has a potential of unsealed pouch packaging.

    FDA · DeviceMICROVENTION INC.US Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA.Official notice →
See all drugs & medical recalls →