Drugs & medicalClass II

Randox Laboratories Ltd. recalls Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and…

Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range

Read the official notice →
Date
2023-01-11
Country
United States
Brand
Randox Laboratories
Product
Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and…
Classification
Class II
Units
US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2023-08-16
  2. US
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    Randox Laboratories Ltd. recalls Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)

    Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea assay is run immediately after…

    FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of CA, DC, GA, OH, OK, MN, MO, NJ, VA…Official notice →
  3. 2023-07-05
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    Randox Laboratories Ltd. recalls Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of…

    Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch…

    FDA · DeviceRandox Laboratories Ltd.CA, IL, VA, WA, WI including PROfficial notice →
  5. 2023-04-05
  6. US
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    Randox Laboratories recalls CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826

    The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range

    FDA · DeviceRandox LaboratoriesPA, OH, WVOfficial notice →
  7. 2022-12-14
  8. US
    Drugs & medicalClass II

    Randox Laboratories Ltd. recalls IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834

    Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133 or FR4030 on the RX instruments testing order. Can lead to…

    FDA · DeviceRandox Laboratories Ltd.US Nationwide Distribution: CA, NC, NJ and WV,Official notice →
  9. 2022-09-28
  10. US
    Drugs & medicalClass II

    Randox Laboratories Ltd. recalls The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV,…

    ***Update** :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckman Coulter DxI. Randox Serology I Positive Control will test negative (Non-Reactive) for Marker HBsAg resulting in delay…

    FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of WV, NC.Official notice →
  11. 2022-07-27
  12. US
    Drugs & medicalClass II

    Randox Laboratories Ltd. recalls Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0

    Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal…

    FDA · DeviceRandox Laboratories Ltd.Nationwide Distribution - MD, OR, PR, MT, WVOfficial notice →
All 27 Randox Laboratories recalls →

Other drugs & medical recalls in the United States

  1. 2023-01-18
  2. US
  3. US
    Drugs & medicalClass II

    RemedyRepack Inc. recalls Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07, Repackaged…

    Failed Impurities/Degradation specifications

    FDA · DrugRemedyRepack Inc.Product was distributed to one account in PA.Official notice →
  4. 2023-01-11
  5. US
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    DeRoyal Industries Inc recalls DeRoyal Tonsillectomy Tray, REF 89-10698.01

    DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may…

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    Windstone Medical Packaging, Inc. recalls Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A…

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    FDA · DeviceWindstone Medical Packaging, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of AZ, CA,…Official notice →
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    Altimate Medical, Inc. recalls ActiveAid 922, Shower/Commode Chair

    Device manufactured with a component with affects the foldability of the frame, not allowing it to be secured by the frame strap in the folded position.

    FDA · DeviceAltimate Medical, Inc.US Nationwide distribution in the state of Texas.Official notice →
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    Detect Headquarters recalls Detect Covid-19 Test Product/Model Number: 21205

    There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of supportive treatment and lack of monitoring…

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See all drugs & medical recalls →