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…
Read the official notice →- Date
- 2022-03-16
- Country
- United States
- Brand
- Cytocell
- Product
- Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Cytocell recalls
- 2023-07-26
USCytocell 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 →- 2022-12-07
- US
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…
- US
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.
- 2022-03-30
- US
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.
- US
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.
Other drugs & medical recalls in the United States
- 2022-03-16
- US
Physio-Control, Inc. recalls HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.
- US
3-D Matrix, Inc. recalls PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006
The boxes used by the shipper were not validated for use during transport.
- US
Medtronic Xomed, Inc. recalls NIM TRIVANTAGE EMG Endotracheal Tube
There is potential for multiple issues due to a manufacturing nonconformity.
FDA · DeviceMedtronic Xomed, Inc.Worldwide distribution - US Nationwide and the countries of Algeria,…Official notice → - US
Nextremity Solutions recalls Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of…
During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in…
FDA · DeviceNextremity SolutionsUS Nationwide distribution in the states of AZ, IL, GA, LA, MD, NY, PA, TX, WA.Official notice → - US
NeuMoDx Molecular Inc recalls NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in…
A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product.
FDA · DeviceNeuMoDx Molecular IncUS Nationwide distribution in the states of FL, MD, MI, NY.Official notice → - US
Bolder Surgical, LLC recalls CoolSeal Generator, REF: CSL-200-50
A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 standards for medical electrical equipment, and it can potentially, under specific conditions, lead to the delivery of…