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.
Read the official notice →- Date
- 2022-12-07
- Country
- United States
- Brand
- Cytocell
- Product
- CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
- Classification
- Class II
- Units
- TX
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
US
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 →- 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…
- 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.
- 2022-03-16
US
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 →
Other drugs & medical recalls in the United States
- 2022-12-07
US
Mobius Imaging, LLC recalls MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. The firm is notifying customers with units whose battery monitoring systems were bypassed to charge the…
FDA · DeviceMobius Imaging, LLCDomestic distribution to consignees in Colorado, Tennessee, and Utah.Official notice →US
Owens & Minor Distribution, Inc. recalls Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection
US
Bio-Rad Laboratories, Inc. recalls CMV IgM EIA, in vitro diagnostic.
Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
FDA · DeviceBio-Rad Laboratories, Inc.U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX O.U.S.: NoneOfficial notice →US
Intuitive Surgical, Inc. recalls INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray…
Potential staple deployment failure and device fragment generation
FDA · DeviceIntuitive Surgical, Inc.U.S.: Arizona, California, Colorado, Florida, Illinois, Indiana, Louisiana,…Official notice →US
Busse Hospital Disposables, Inc. recalls Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1
Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable
US
GS Biomark LLC recalls CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200…
Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization.
FDA · DeviceGS Biomark LLCU.S.: TX, NY, GA, IN, MD, CA, PA, MD, DC, NJ, OR, WA O.U.S.: NoneOfficial notice →