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MGB Alert® BKV Probe Mix ASR-48rxn

Elitechgroup Mdx LLC · Model 800421 · UDI-DI 03661540951534

MVU

510(k) clearances

Adverse events

Recalls

116

Facilities

Description

"MGB Alert® BK Virus Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from BK Virus. The mix consists of one probe at 1.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6- carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm."

Recalls

Date	Firm	Reason
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.
2024-11-01	Kreatech Biotechnology Bv	The DNA fragments for this specific lot number are too large, resulting in potential background around the cells due to suboptimal hybridization. An absence of signal could also be
2024-02-01	Abbott Molecular, Inc.	Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
2023-10-25	Becton, Dickinson and Company, BD Biosciences	In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis
2023-05-24	Cytocell Ltd.	DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
2023-05-24	Cytocell Ltd.	DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
2022-10-27	Cytocell Ltd.	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
2022-10-27	Cytocell Ltd.	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 t
2022-03-25	Becton, Dickinson and Company, BD Biosciences	Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
2022-03-25	Becton, Dickinson and Company, BD Biosciences	Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.