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…
Read the official notice →- Date
- 2022-12-07
- Country
- United States
- Brand
- Cytocell
- Product
- CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
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 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.
- 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
- 2022-12-14
- US
Fresenius Medical Care Holdings, Inc. recalls 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs,…
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
FDA · DrugFresenius Medical Care Holdings, Inc.Product was distributed Nationwide in the USA.Official notice → - 2022-12-12
- US
AlEn USA Recalls Art of Green® Laundry Detergent Products Due to Risk of Exposure to Bacteria
The recalled products can contain bacteria, including Pseudomonas aeruginosa, an environmental organism found widely in soil and water. People with weakened immune systems or external medical devices who are exposed to…
- 2022-12-07
- US
Alcon Research, LLC recalls Alcon Custom Pak Surgical Procedure Pack
Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes has observed an increase in reported…
FDA · DeviceAlcon Research, LLCWorldwide Distribution: U.S.(nationwide) to states of: AK, AL, AR, AZ, CA, CO,…Official notice → - US
Primus Corporation dba Trinity Biotech recalls A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052,…
The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. The unacceptable Control Level 1 value results in the Analyzer generating an…
FDA · DevicePrimus Corporation dba Trinity BiotechTurkey, India, Romania, Thailand, Vietnam, S. Korea, Peru, Pakistan Austria,…Official notice → - US
Greer Laboratories, Inc. recalls GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for…
The product was recalled because stability evaluation of the lots indicated a decrease in reactivity that could lead to a potential false-negative result interpretation. The issue was identified by the firm after…
FDA · DeviceGreer Laboratories, Inc.US Distribution to states of: CA, CO, IA, KY, MA, MD, MO, NC, PA, UT, VA, and…Official notice → - US
Accelerate Diagnostics Inc recalls Accelerate PhenoTest BC kit REF 10101018
Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.
FDA · DeviceAccelerate Diagnostics IncU.S.: AR, CA, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, MS, MT,…Official notice →