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MGB Alert® BKV Primer Mix ASR - 480 Reactions QTY 25

ELITECH GROUP INC. · Model 800332-25 · UDI-DI 03661540952272

MVU

510(k) clearances

Adverse events

Recalls

116

Facilities

Description

MGB Alert® BK Virus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from BK Virus. The mix consists of a total of 2.6 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 72 nucleic acid sequence from the VP1 region of BK Virus. QTY 25 @ 480 reactions.

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.