Drugs & medicalClass III

Cytocell Ltd. recalls TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome…

May show unexpected locus specific signals in addition to those at 14q32.

Read the official notice →
Date
2022-03-30
Country
United States
Brand
Cytocell
Product
TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome…
Classification
Class III
Units
MN
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Cytocell recalls

  1. 2023-07-26
  2. US
    Drugs & medicalClass II

    Cytocell Ltd. recalls RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA…

    DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.

    FDA · DeviceCytocell Ltd.US Nationwide distribution in the states of CA, FL, OH, & SC.Official notice →
  3. 2022-12-07
  4. US
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    Cytocell Ltd. recalls CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent…

    Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FISH probe maps to on the specific chromosome. For this device the chromomap in version 1 of the…

    FDA · DeviceCytocell Ltd.TXOfficial notice →
  5. US
    Drugs & medicalClass II

    Cytocell Ltd. recalls CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782

    An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using the wrong coordinates.

    FDA · DeviceCytocell Ltd.TXOfficial notice →
  6. 2022-03-30
  7. US
    Drugs & medicalClass III

    Cytocell Ltd. recalls Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008

    Labelled with an incorrect expiry date on the outer label with an extended expiry date than the validated shelf life. The correct expiry date for the device is 2022-02 and not 2023-05 as shown on the outer label.

    FDA · DeviceCytocell Ltd.US Nationwide distribution in the states of CT, TX.Official notice →
  8. 2022-03-16
  9. US
    Drugs & medicalClass II

    Cytocell Ltd. recalls Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog…

    individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in green rather than red and the control…

    FDA · DeviceCytocell Ltd.US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania,…Official notice →
All 6 Cytocell recalls →

Other drugs & medical recalls in the United States

  1. 2022-03-30
  2. US
    Drugs & medicalClass II

    Baxter Healthcare Corporation recalls Compella Therapy Air Supply Unit

    Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.

    FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of Australia,…Official notice →
  3. US
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    B Braun Medical Inc recalls PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog…

    Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy,…

    FDA · DeviceB Braun Medical IncUS Distribution to states of: MA, VTOfficial notice →
  4. US
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    Integra LifeSciences Corp. recalls Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device…

    Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur

    FDA · DeviceIntegra LifeSciences Corp.Worldwide distribution - US Nationwide and the country of Hong Kong.Official notice →
  5. US
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    Outset Medical, Inc. recalls Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000

    Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.

    FDA · DeviceOutset Medical, Inc.U.S. Nationwide distribution in the states of AL, AK, AZ, CA, CO, CT, DC, DE,…Official notice →
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    Biomet, Inc. recalls BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, which…

    Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of…

    FDA · DeviceBiomet, Inc.Worldwide: US (28 States AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA,…Official notice →
  7. US
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    Philips Respironics, Inc. recalls Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home,…

    In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based polyurethane (PE-PUR) foam may degrade into particles. This 2018…

    FDA · DevicePhilips Respironics, Inc.Global Distribution. US Nationwide.Official notice →
See all drugs & medical recalls →